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.

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

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.

Conditions studied

Convergence Insufficiency
Divergence Insufficiency
Hypertropia

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Keywords

Convergence Insufficiency
Divergence Insufficiency
Small-angle Hypertropia
Strabismus

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

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

What researchers measure

Primary outcomes

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
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

Mean of Near Point of Convergence in Convergence Insufficiency Group
Near point of convergence (convergence insufficiency group only).
Time frame: 12 months after enrollment
Mean Positive Fusional Vergence in Convergence Insufficiency Group
Positive fusional vergence (convergence insufficiency group only).
Time frame: 12 months after enrollment
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
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
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

Results

Posted Apr 8, 2021

Participant flow

Participant flow — Overall Study
Milestone	Convergence Insufficiency	Divergence Insufficiency	Small-angle Hypertropia
Started	81	114	22
Completed	63	111	21
Not completed	18	3	1
Withdrew: Deemed no longer eligible	18	3	1

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
Participants	Convergence Insufficiency	Divergence Insufficiency	Small-angle Hypertropia
Number of Participants With Symptom Success at 10 Weeks	25	91	12

PrimaryNumber of Participants With Symptom Success at 12 Months

Time frame:: 12 months after enrollment
Reported as:: Count of participants · Participants

Number of Participants With Symptom Success at 12 Months
Participants	Convergence Insufficiency	Divergence Insufficiency	Small-angle Hypertropia
Number of Participants With Symptom Success at 12 Months	25	73	6

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
centimeters	Convergence Insufficiency
Mean of Near Point of Convergence in Convergence Insufficiency Group	14.1 ± 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 diopters	Convergence Insufficiency
Mean Positive Fusional Vergence in Convergence Insufficiency Group	11.6 ± 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 scale	Divergence Insufficiency
General Function Score	62 ± 22
Reading Function Score	71 ± 23
Self Perception Score	87 ± 19
Interaction Score	94 ± 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
points	Convergence Insufficiency
Mean Convergence Insufficiency Symptom Survey Score	37.5 ± 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)
points	Convergence Insufficiency
General Function	55.7 ± 24.6
Reading Function	43.9 ± 22.2
Interaction	92.2 ± 14.7
Self Perception	83.8 ± 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
Group	Deaths	Serious	Other
Convergence Insufficiency	—	—	—
Divergence Insufficiency	—	—	—
Small-angle Hypertropia	—	—	—

Baseline characteristics

Age, Continuous
Age, Continuous(years)	Convergence Insufficiency	Divergence Insufficiency	Small-angle Hypertropia	Total
Mean	42.4 ± 18.6	67.4 ± 13.7	68.6 ± 13.0	59.5 ± 19.4

Age, Continuous
Age, Continuous(years)	Convergence Insufficiency	Divergence Insufficiency	Small-angle Hypertropia	Total
Median	38.2 (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 Insufficiency	Divergence Insufficiency	Small-angle Hypertropia	Total
Female	48	74	10	132
Male	15	37	11	63

Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)	Convergence Insufficiency	Divergence Insufficiency	Small-angle Hypertropia	Total
White	32	107	19	158
Non-white	31	4	2	37

Study locations

1 site

Earl R. Crouch, III
Norfolk, Virginia 23502-3942, United States

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

Study protocol · Apr 11, 2016
Statistical analysis plan · Jun 4, 2020
Informed consent form · Aug 10, 2015

Documents are hosted by the registry — open the source record to download them.

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, Sap, Icf

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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A Prospective Observational Study of Adult Strabismus

Study summary

Conditions studied

Browse trials for

Keywords

Who can participate

Study population

Eligibility criteria

Study design

Groups and cohorts

Interventions

What researchers measure

Primary outcomes

Secondary outcomes

Results

Participant flow

Outcome measures

Adverse events

Baseline characteristics

Study locations

References and documents

Publications

Related links

Study documents

Individual participant data

Registry details

Key details

Study contacts

Oversight

Not currently enrolling

Follow this study

Discussion

Other studies in this condition

Other studies from this sponsor