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CompletedNCT02510040SAS1Updated Jul 6, 2023Results posted

A Prospective Observational Study of Adult Strabismus

An observational study in Convergence Insufficiency, Divergence Insufficiency and Hypertropia, sponsored by Jaeb Center for Health Research. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-07-06.

Primary conditionStrabismusRegistry: Ocular Motility DisordersReclassifiedWhy we changed it
Registry
Ocular Motility Disorders — the first condition term the registry derived for this study.
ClinicalTrials.gg
Strabismus
Why
  1. The study's listed conditions name Strabismus, a narrower term within Ocular Motility Disorders.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by Jaeb Center for Health Research · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
217
Ages
18 Years and older
Sex
All
01

Study summary

The purpose of this study is to describe clinical characteristics, treatments, and one-year outcomes of adults with convergence insufficiency, divergence insufficiency, or small angle hypertropia.

Read the detailed description

The purpose of this study is to describe clinical characteristics, treatments, and one-year outcomes of adults with convergence insufficiency, divergence insufficiency, or small angle hypertropia. Treatment comparisons within the studied conditions will also be done to help develop future studies.

02

Conditions studied

  • Convergence Insufficiency
  • Divergence Insufficiency
  • Hypertropia

Browse trials for

Keywords

  • Convergence Insufficiency
  • Divergence Insufficiency
  • Small-angle Hypertropia
  • Strabismus
03

In context

Strabismus Reclassified

142 studies on the registry are indexed under Strabismus; 31 are open to participants now.

This study's enrollment of 217 is above the median of 96 across 54 observational studies indexed under Strabismus.

Browse Strabismus studies →

Lead sponsor

Jaeb Center for Health Research is the lead sponsor of 129 studies on the registry; 16 are open to participants now.

Of its 17 completed or terminated interventional studies of FDA-regulated products, 15 (88%) have results posted.

Browse Jaeb Center for Health Research studies →

Compared within Strabismus, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Ocular Motility Disorders. The counts are of registry records indexed under each term, refreshed daily. How we classify →

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Community Sample

Eligibility criteria

Eligibility Criteria for Convergence Insufficiency (CI) Group:

The following inclusion criteria must be met for the subject to be enrolled into the study:

  • Adults ≥18 years of age (adult onset of CI not required)
  • No strabismus surgery within the past 10 years
  • CI Symptom Survey score ≥21 points
  • Near exodeviation of ≥4∆ and at least 4∆ larger than at distance by PACT
  • Distance exodeviation ≤15∆ by PACT
  • Vertical deviation ≤2∆ at distance and near by PACT
  • No constant exotropia at distance or near
  • Reduced positive fusional vergence (PFV) at near (\<20∆ or fails Sheard's criterion that the PFV measures less than twice the magnitude of the near phoria)
  • Near point of convergence (NPC) of ≥6 cm break
  • Visual acuity 20/50 or better in both eyes by ETDRS or Snellen
  • No paralytic strabismus (e.g., 3rd, 4th, or 6th cranial nerve palsies, skew deviation, Duane syndrome)
  • No restrictive strabismus (e.g., blowout fracture, thyroid eye disease, post scleral buckle, Brown syndrome)
  • No monocular diplopia
  • No paretic strabismus, thyroid eye disease, myasthenia gravis, chronic progressive external ophthalmoplegia, or eye movement abnormalities associated with known neurological disease. Patients with Parkinson's disease can be enrolled if non-paretic deviation.
  • No inferior or superior oblique overaction defined as 2+ or greater
  • Ability to fuse with prism in space (see section 2.4.1)
  • Ability to understand and complete a survey
  • Investigator is initiating treatment with prism, orthoptic exercises, botulinum toxin injection or surgery
  • If initiating treatment with botulinum toxin or surgery, planned injection or surgery to be within 60 days of enrollment
  • Single treatment modality is planned (e.g., no combined prism and orthoptic exercises)
  • Treatment to be initiated has not been used within the past one year

Eligibility Criteria for Divergence Insufficiency (DI) Group:

The following inclusion criteria must be met for the subject to be enrolled into the study:

  • Adults ≥18 years of age
  • Adult-onset DI (at ≥18 years of age)
  • No prior strabismus surgery
  • Symptoms of diplopia at distance with a frequency of sometimes or worse in primary position (in current glasses if wearing glasses)
  • Distance esodeviation of 2∆ to 30∆ and at least 50% larger than at near by PACT
  • No more than 5∆ difference between right and left gaze by PACT
  • No more than 10∆ difference between the primary position at distance and either upgaze or downgaze ≤10∆ by PACT
  • Any coexisting vertical deviation must be less than distance esodeviation and ≤10∆ by PACT
  • Visual acuity 20/50 or better in both eyes by ETDRS or Snellen
  • No paralytic strabismus (e.g., 3rd, 4th, or 6th cranial nerve palsies, skew deviation, Duane syndrome)
  • No restrictive strabismus (e.g., blowout fracture, thyroid eye disease, post scleral buckle, Brown syndrome)
  • No monocular diplopia
  • No paretic strabismus, thyroid eye disease, myasthenia gravis, chronic progressive external ophthalmoplegia, or eye movement abnormalities associated with known neurological disease. Patients with Parkinson's disease can be enrolled if non-paretic deviation
  • No inferior or superior oblique overaction defined as 2+ or greater
  • Ability to fuse with prism in space (see section 2.4.2)
  • Ability to understand and complete a survey
  • Investigator is initiating treatment with prism, orthoptic exercises, botulinum toxin injection or surgery
  • If initiating treatment with botulinum toxin or surgery, planned injection or surgery to be within 60 days of enrollment
  • Single treatment modality planned (e.g., no combined prism and orthoptic exercises)
  • Treatment to be initiated has not been used within the past one year

Eligibility Criteria for Small-angle Hypertropia (HT) Group:

The following inclusion criteria must be met for the subject to be enrolled into the study:

  • Adults ≥18 years of age
  • Adult-onset HT (at ≥18 years of age)
  • No prior strabismus surgery
  • Symptoms of diplopia at distance or near with a frequency of sometimes or worse in primary or reading position (in current glasses if wearing glasses)
  • Vertical deviation ≥1∆ to ≤10∆ at distance and near by PACT
  • No more than 4∆ difference from the primary in any gaze position by PACT
  • Any coexisting esodeviation must be less than the vertical deviation
  • Any coexisting exodeviation ≤10∆ by PACT
  • No convergence insufficiency as defined in section 2.2.1
  • Visual acuity 20/50 or better in both eyes by ETDRS or Snellen
  • No paralytic strabismus (e.g., 3rd, 4th, or 6th cranial nerve palsies, skew deviation, Duane syndrome)
  • No restrictive strabismus (e.g., blowout fracture, thyroid eye disease, post scleral buckle, Brown syndrome)
  • No monocular diplopia
  • No paretic strabismus, thyroid eye disease, myasthenia gravis, chronic progressive external ophthalmoplegia, or eye movement abnormalities associated with known neurological disease. Patients with Parkinson's disease can be enrolled if non-paretic deviation.
  • No inferior or superior oblique overaction defined as 2+ or greater
  • Ability to fuse with prism in space (see section 2.4.3)
  • Ability to understand and complete a survey
  • Investigator is initiating treatment with prism, orthoptic exercises, botulinum toxin injection or surgery
  • If initiating treatment with botulinum toxin or surgery, planned injection or surgery to be within 60 days of enrollment
  • Single treatment modality planned (e.g., no combined prism and orthoptic exercises)
  • Treatment to be initiated has not been used within the past one year

Exclusion Criteria for Convergence Insufficiency (CI) Group:

The following criteria exclude a subject from enrollment into the study:

  • Strabismus surgery within the past 10 years
  • CI Symptom Survey score ≥21 points
  • Near exodeviation of ≤4∆ and at least 4∆ larger than at distance by PACT
  • Distance exodeviation ≥15∆ by PACT
  • Vertical deviation ≥2∆ at distance and near by PACT
  • Constant exotropia at distance or near
  • Near point of convergence (NPC) of ≤6 cm break
  • Visual acuity worse than 20/50 either eye by ETDRS or Snellen
  • Paralytic strabismus (e.g., 3rd, 4th, or 6th cranial nerve palsies, skew deviation, Duane syndrome)
  • Restrictive strabismus (e.g., blowout fracture, thyroid eye disease, post scleral buckle, Brown syndrome)
  • Monocular diplopia
  • Paretic strabismus, thyroid eye disease, myasthenia gravis, chronic progressive external ophthalmoplegia, or eye movement abnormalities associated with known neurological disease. Patients with Parkinson's disease can be enrolled if non-paretic deviation.
  • Inferior or superior oblique overaction defined as 2+ or greater
  • Inability to fuse with prism in space (see section 2.4.1)
  • Inability to understand and complete a survey
  • Treatment to be initiated has already been used within the past one year

Exclusion Criteria for Divergence Insufficiency (DI) Group:

The following criteria exclude a subject from enrollment into the study:

  • No adult-onset DI (at ≥18 years of age)
  • Prior strabismus surgery
  • Distance esodeviation outside the range of 2∆ to 30∆ and less than 50% larger than at near by PACT
  • More than 5∆ difference between right and left gaze by PACT
  • More than 10∆ difference between the primary position at distance
  • Any coexisting vertical deviation more than distance esodeviation and ≥10∆ by PACT
  • Visual acuity worse than 20/50 in either eye by ETDRS or Snellen
  • Paralytic strabismus (e.g., 3rd, 4th, or 6th cranial nerve palsies, skew deviation, Duane syndrome)
  • Restrictive strabismus (e.g., blowout fracture, thyroid eye disease, post scleral buckle, Brown syndrome)
  • Monocular diplopia
  • Paretic strabismus, thyroid eye disease, myasthenia gravis, chronic progressive external ophthalmoplegia, or eye movement abnormalities associated with known neurological disease.
  • Inferior or superior oblique overaction defined as 2+ or greater
  • Inability to fuse with prism in space (see section 2.4.2)
  • Inability to understand and complete a survey
  • Treatment to be initiated has already been used within the past one year

Exclusion Criteria for Small-angle Hypertropia (HT) Group:

The following criteria exclude a subject from enrollment into the study:

  • No adult-onset HT (at ≥18 years of age)
  • Prior strabismus surgery
  • Vertical deviation ≤1∆ or ≥10∆ at distance and near by PACT
  • More than 4∆ difference from the primary in any gaze position by PACT
  • Coexisting esodeviation must not be less than the vertical deviation
  • Coexisting exodeviation ≥10∆ by PACT
  • Convergence insufficiency as defined in section 2.2.1
  • Visual acuity worse than 20/50 in either eye by ETDRS or Snellen
  • Paralytic strabismus (e.g., 3rd, 4th, or 6th cranial nerve palsies, skew deviation, Duane syndrome)
  • Restrictive strabismus (e.g., blowout fracture, thyroid eye disease, post scleral buckle, Brown syndrome)
  • Monocular diplopia
  • Paretic strabismus, thyroid eye disease, myasthenia gravis, chronic progressive external ophthalmoplegia, or eye movement abnormalities associated with known neurological disease.
  • Inferior or superior oblique overaction defined as 2+ or greater
  • Inability to fuse with prism in space (see section 2.4.3)
  • Inability to understand and complete a survey
  • Treatment to be initiated has already been used within the past one year
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
217 participants (actual)
Patient registry
No

Groups and cohorts

  • Convergence insufficiency

    Eligible adults with convergence insufficiency can be treated with prism, orthoptic exercises, eye muscle surgery, or botox injection, per the investigator's usual clinical practice.

    Device: Prism · Other: Orthoptic Exercises · Procedure: Eye Muscle Surgery · Procedure: Botox Injection

  • Divergence insufficiency

    Eligible adults with divergence insufficiency can be treated with prism, orthoptic exercises, eye muscle surgery, or botox injection, per the investigator's usual clinical practice.

    Device: Prism · Other: Orthoptic Exercises · Procedure: Eye Muscle Surgery · Procedure: Botox Injection

  • Small-angle hypertropia

    Eligible adults with small-angle hypertropia can be treated with prism, orthoptic exercises, eye muscle surgery, or botox injection, per the investigator's usual clinical practice.

    Device: Prism · Other: Orthoptic Exercises · Procedure: Eye Muscle Surgery · Procedure: Botox Injection

Interventions

  • DevicePrism

    Ground-in or Fresnel prism

  • OtherOrthoptic Exercises

    Orthoptic exercises- fusion, convergence, divergence, and others, including computer-based therapy

  • ProcedureEye Muscle Surgery

    * Bilateral medial rectus muscle resection surgery * Single medial rectus muscle resection surgery * Recess lateral rectus muscle resection medial rectus muscle surgery * Bilateral lateral rectus muscle recession surgery * Single lateral rectus muscle recession surgery * Bilateral lateral rectus muscle resection surgery * Single lateral rectus muscle resection surgery * Recess medial rectus muscle resection lateral rectus muscle surgery * Bilateral medial rectus muscle recession surgery * Single medial rectus muscle recession surgery * Vertical rectus muscle recession surgery * Vertical rectus muscle mini-tenotomy (snip) surgery

  • ProcedureBotox Injection

    Botulinum toxin injection

    Also known as: Botulinum toxin injection

06

What researchers measure

Primary outcomes

  1. Number of Participants With Symptom Success at 10 Weeks

    In the convergence insufficiency group, the primary outcome will be symptom success at the 10-week and 12-month visit, defined as improvement of CI Symptom Survey (CISS) score of at least 9 points and an outcome score of \<21 points. In the divergence insufficiency group, the primary outcome will be symptom success at the 10-week and 12-month visit, defined as diplopia "rarely" or "never" in primary position at distance on the diplopia questionnaire. In the small-angle hypertropia group, the primary outcome will be symptom success at the 10-week and 12-month visit, defined as diplopia "rarely" or "never" both in primary position at distance and in reading position on the diplopia questionnaire.

    Time frame: 10 weeks after enrollment

  2. Number of Participants With Symptom Success at 12 Months

    In the convergence insufficiency group, the primary outcome will be symptom success at the 10-week and 12-month visit, defined as improvement of CI Symptom Survey (CISS) score of at least 9 points and an outcome score of \<21 points. In the divergence insufficiency group, the primary outcome will be symptom success at the 10-week and 12-month visit, defined as diplopia "rarely" or "never" in primary position at distance on the diplopia questionnaire. In the small-angle hypertropia group, the primary outcome will be symptom success at the 10-week and 12-month visit, defined as diplopia "rarely" or "never" both in primary position at distance and in reading position on the diplopia questionnaire.

    Time frame: 12 months after enrollment

Secondary outcomes

  1. Mean of Near Point of Convergence in Convergence Insufficiency Group

    Near point of convergence (convergence insufficiency group only).

    Time frame: 12 months after enrollment

  2. Mean Positive Fusional Vergence in Convergence Insufficiency Group

    Positive fusional vergence (convergence insufficiency group only).

    Time frame: 12 months after enrollment

  3. Adult Strabismus 20 Questionnaire Score (DI)

    Adult Strabismus Quality of Life Questionnaire (AS-20) For AS-20, scores are reported for the following subscales. A total score will not be reported. 1. Self-perception score 2. Interaction score 3. Reading function score 4. General function score Values for each subscale range from 0 to 100. 0 indicates poor quality of life (the patient reported "always" for all questions) and 100 represents good quality or life (patient reported "never" for all questions)

    Time frame: 12 months after enrollment

  4. Mean Convergence Insufficiency Symptom Survey Score

    Mean Convergence Insufficiency Symptom Survey Score (convergence insufficiency group only) For CISS, the range is from 0 (having no symptoms of CI) to 60 (always showing all symptoms of CI).

    Time frame: 12 months after enrollment

  5. Adult Strabismus 20 Questionnaire Score (CI)

    Adult Strabismus Quality of Life Questionnaire (AS-20) For AS-20, scores are reported for the following subscales. A total score will not be reported. Self-perception score Interaction score Reading function score General function score Values for each subscale range from 0 to 100. 0 indicates poor quality of life (the patient reported "always" for all questions) and 100 represents good quality or life (patient reported "never" for all questions)

    Time frame: 12 months after enrollment

07

Results

Posted Apr 8, 2021

Participant flow

Participant flow — Overall Study
MilestoneConvergence InsufficiencyDivergence InsufficiencySmall-angle Hypertropia
Started8111422
Completed6311121
Not completed1831
Withdrew: Deemed no longer eligible1831

Outcome measures

PrimaryNumber of Participants With Symptom Success at 10 Weeks

In the convergence insufficiency group, the primary outcome will be symptom success at the 10-week and 12-month visit, defined as improvement of CI Symptom Survey (CISS) score of at least 9 points and an outcome score of \<21 points. In the divergence insufficiency group, the primary outcome will be symptom success at the 10-week and 12-month visit, defined as diplopia "rarely" or "never" in primary position at distance on the diplopia questionnaire. In the small-angle hypertropia group, the primary outcome will be symptom success at the 10-week and 12-month visit, defined as diplopia "rarely" or "never" both in primary position at distance and in reading position on the diplopia questionnaire.

Time frame:
10 weeks after enrollment
Reported as:
Count of participants · Participants
Number of Participants With Symptom Success at 10 Weeks
ParticipantsConvergence InsufficiencyDivergence InsufficiencySmall-angle Hypertropia
Number of Participants With Symptom Success at 10 Weeks259112
PrimaryNumber of Participants With Symptom Success at 12 Months

In the convergence insufficiency group, the primary outcome will be symptom success at the 10-week and 12-month visit, defined as improvement of CI Symptom Survey (CISS) score of at least 9 points and an outcome score of \<21 points. In the divergence insufficiency group, the primary outcome will be symptom success at the 10-week and 12-month visit, defined as diplopia "rarely" or "never" in primary position at distance on the diplopia questionnaire. In the small-angle hypertropia group, the primary outcome will be symptom success at the 10-week and 12-month visit, defined as diplopia "rarely" or "never" both in primary position at distance and in reading position on the diplopia questionnaire.

Time frame:
12 months after enrollment
Reported as:
Count of participants · Participants
Number of Participants With Symptom Success at 12 Months
ParticipantsConvergence InsufficiencyDivergence InsufficiencySmall-angle Hypertropia
Number of Participants With Symptom Success at 12 Months25736
SecondaryMean of Near Point of Convergence in Convergence Insufficiency Group

Near point of convergence (convergence insufficiency group only).

Time frame:
12 months after enrollment
Reported as:
Mean · centimeters
Mean of Near Point of Convergence in Convergence Insufficiency Group
centimetersConvergence Insufficiency
Mean of Near Point of Convergence in Convergence Insufficiency Group14.1 ± 6.2
SecondaryMean Positive Fusional Vergence in Convergence Insufficiency Group

Positive fusional vergence (convergence insufficiency group only).

Time frame:
12 months after enrollment
Reported as:
Mean · prism diopters
Mean Positive Fusional Vergence in Convergence Insufficiency Group
prism dioptersConvergence Insufficiency
Mean Positive Fusional Vergence in Convergence Insufficiency Group11.6 ± 7.1
SecondaryAdult Strabismus 20 Questionnaire Score (DI)

Adult Strabismus Quality of Life Questionnaire (AS-20) For AS-20, scores are reported for the following subscales. A total score will not be reported. 1. Self-perception score 2. Interaction score 3. Reading function score 4. General function score Values for each subscale range from 0 to 100. 0 indicates poor quality of life (the patient reported "always" for all questions) and 100 represents good quality or life (patient reported "never" for all questions)

Time frame:
12 months after enrollment
Reported as:
Mean · score on a scale
Adult Strabismus 20 Questionnaire Score (DI)
score on a scaleDivergence Insufficiency
General Function Score62 ± 22
Reading Function Score71 ± 23
Self Perception Score87 ± 19
Interaction Score94 ± 11
SecondaryMean Convergence Insufficiency Symptom Survey Score

Mean Convergence Insufficiency Symptom Survey Score (convergence insufficiency group only) For CISS, the range is from 0 (having no symptoms of CI) to 60 (always showing all symptoms of CI).

Time frame:
12 months after enrollment
Reported as:
Mean · points
Mean Convergence Insufficiency Symptom Survey Score
pointsConvergence Insufficiency
Mean Convergence Insufficiency Symptom Survey Score37.5 ± 9.1
SecondaryAdult Strabismus 20 Questionnaire Score (CI)

Adult Strabismus Quality of Life Questionnaire (AS-20) For AS-20, scores are reported for the following subscales. A total score will not be reported. Self-perception score Interaction score Reading function score General function score Values for each subscale range from 0 to 100. 0 indicates poor quality of life (the patient reported "always" for all questions) and 100 represents good quality or life (patient reported "never" for all questions)

Time frame:
12 months after enrollment
Reported as:
Mean · points
Adult Strabismus 20 Questionnaire Score (CI)
pointsConvergence Insufficiency
General Function55.7 ± 24.6
Reading Function43.9 ± 22.2
Interaction92.2 ± 14.7
Self Perception83.8 ± 22.6

Adverse events

Collected over Adverse event data was not collected since treatment was prescribed per usual standard of care.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Convergence Insufficiency———
Divergence Insufficiency———
Small-angle Hypertropia———

Baseline characteristics

Age, Continuous
Age, Continuous(years)Convergence InsufficiencyDivergence InsufficiencySmall-angle HypertropiaTotal
Mean42.4 ± 18.667.4 ± 13.768.6 ± 13.059.5 ± 19.4
Age, Continuous
Age, Continuous(years)Convergence InsufficiencyDivergence InsufficiencySmall-angle HypertropiaTotal
Median38.2 (25.6 to 57.2)71.2 (60.8 to 75.7)71.5 (65.7 to 76.6)65.3 (44.2 to 74.1)
Sex: Female, Male
Sex: Female, Male(Participants)Convergence InsufficiencyDivergence InsufficiencySmall-angle HypertropiaTotal
Female487410132
Male15371163
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)Convergence InsufficiencyDivergence InsufficiencySmall-angle HypertropiaTotal
White3210719158
Non-white314237
08

Study locations

1 site
  • Earl R. Crouch, III
    Norfolk, Virginia 23502-3942, United States
09

References and documents

Publications

  • Crouch ER, Dean TW, Kraker RT, Miller AM, Kraus CL, Gunton KB, Repka MX, Marsh JD, Del Monte MA, Luke PA, Peragallo JH, Lee KA, Wheeler MB, Daley TJ, Wallace DK, Cotter SA, Holmes JM; Pediatric Eye Disease Investigator Group. A prospective study of treatments for adult-onset divergence insufficiency-type esotropia. J AAPOS. 2021 Aug;25(4):203.e1-203.e11. doi: 10.1016/j.jaapos.2021.02.014. Epub 2021 Jul 13. PubMed 34271207 ↗
  • Lorenzana IJ, Leske DA, Hatt SR, Dean TW, Jenewein EC, Dagi LR, Beal CJ, Pang Y, Retnasothie DV, Esposito CA, Erzurum SA, Aldrich AE, Crouch ER, Li Z, Kraker RT, Holmes JM, Cotter SA; Pediatric Eye Disease Investigator Group; Pediatric Eye Disease Investigator Group. Relationships among Clinical Factors and Patient-reported Outcome Measures in Adults with Convergence Insufficiency. Optom Vis Sci. 2022 Sep 1;99(9):692-701. doi: 10.1097/OPX.0000000000001929. Epub 2022 Aug 2. PubMed 35914096 ↗

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: Yes — In accordance with the NIH data sharing policy, a de-identified database is placed in the public domain on the Pediatric Eye Disease Investigator Group (PEDIG) public website after the completion of each protocol and publication of the primary manuscript.

Supporting information: Study protocol, Statistical analysis plan, Informed consent form

Time frame: After completion of the protocol and publication of the primary manuscript, the data will be made available for the duration of the grant and any future grants.

Access criteria: public

10

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Aug 2015 to primary completion in Dec 2017, 28 months.

Results were first posted in Apr 2021, 3 years 3 months after primary completion.

Of 26 observational studies under Strabismus, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 50. This study's 28 months is above that.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 24, 2015
First posted
Jul 28, 2015
StartActual
Aug 17, 2015
Primary completionActual
Dec 31, 2017
CompletionActual
Jan 31, 2019
Results first posted
Apr 8, 2021
Last update
Jul 6, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 6, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT02510040
Lead sponsor
Jaeb Center for Health Research
Collaborators
Pediatric Eye Disease Investigator Group, National Eye Institute (NEI)
Responsible party
Sponsor
First posted
Jul 28, 2015
Start date
Aug 17, 2015
Primary completion
Dec 31, 2017
Completion
Jan 31, 2019
Results posted
Apr 8, 2021
Last update
Jul 6, 2023

Study contacts

Earl R Crouch, III, MD
study chair · Virginia Pediatric Eye Center

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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