ClinicalTrials.gg
Status unknownNCT03431454Updated Feb 13, 2018

Comparison of Three Vision Therapy Approaches for Convergence Insufficiency

A Phase 2 interventional study of trained to do the pencil push-ups procedure and using a major amblyoscope twice weekly with additional home orthoptic therapy in Comparison of Three Vision Therapy Approaches for Convergence Insufficiency, sponsored by Shahid Beheshti University of Medical Sciences. Status unknown at 1 site in Iran, Islamic Republic of. Open to participants aged 15 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-02-13.

Sponsored by Shahid Beheshti University of Medical Sciences · Phase 2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Dec 2017), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 2
Study type
Interventional
Enrollment
48
Allocation
Randomized
Ages
15 Years to 35 Years
Sex
All
01

Study summary

We compared the effectiveness of three active vision therapy approaches for convergence insufficiency (CI). Patients with eligible criteria and symptomatic CI were included in a prospective study and randomly allocated into three groups. In the home-based vision orthoptic therapy (HBVOT) group, patients were trained to do the pencil push-ups procedure 15 minutes per day, five days a week. In the office-based vision orthoptic therapy (OBVOT) group, 60 minutes of orthoptic therapy using a major amblyoscope twice weekly with additional home orthoptic therapy was prescribed. For the augmented office-based vision orthoptic therapy (AOBVOT) group, orthoptic exercises using three diopter over-minus lenses and a base out prism, in addition to major amblyoscope and additional home reinforcement was prescribed in the same period of time.

02

Conditions studied

  • Comparison of Three Vision Therapy Approaches for Convergence Insufficiency
03

In context

Ocular Motility Disorders

58 studies on the registry are indexed under Ocular Motility Disorders; 20 are open to participants now.

This study's planned enrollment of 48 is below the median of 91 across 40 interventional studies indexed under Ocular Motility Disorders.

Browse Ocular Motility Disorders studies →

Lead sponsor

Shahid Beheshti University of Medical Sciences is the lead sponsor of 229 studies on the registry; 19 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
15 Years to 35 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • patients between 15 and 35 years of age who have symptomatic CI using the Convergence Insufficiency Symptom Survey (CISS) scoring system.
  • best-corrected visual acuity ≥ 20/25
  • exophoria at near at least 4 prism diopters (△) greater than at distance
  • near point of convergence more than 6.0 cm break
  • insufficient positive fusional vergence (PFV) (failing Sheard's criterion or PFV ≤ 15 △ base-out) at near distance.

Exclusion criteria

Exclusion Criteria:

  • amblyopia (VA worse than 20/30 in each eye), presence of manifest strabismus, history of ocular surgery, any systemic disorder, anisometropia of more than 1.5 diopter of myopia or hyperopia or significant refractive error, and nystagmus and usage of medications that may impair accommodation or convergence. ,ocular surface abnormalities or history of ocular allergy or those who had previously been treated for CI
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Care provider)
Enrollment
48 participants (estimated)

Study arms

  • Active comparator
    home-based vision orthoptic therapy (HBVOT) group

    In the home-based vision orthoptic therapy (HBVOT) group, patients were trained to do the pencil push-ups procedure 15 minutes per day, five days a week

    Procedure: trained to do the pencil push-ups procedure

  • Active comparator
    office-based vision orthoptic therapy (OBVOT) group

    In the office-based vision orthoptic therapy (OBVOT) group, 60 minutes of orthoptic therapy using a major amblyoscope twice weekly with additional home orthoptic therapy was prescribed

    Procedure: using a major amblyoscope twice weekly with additional home orthoptic therapy

  • Active comparator
    augmented office-based vision orthoptic therapy (AOBVOT) group

    For the augmented office-based vision orthoptic therapy (AOBVOT) group, orthoptic exercises using three diopter over-minus lenses and a base out prism, in addition to major amblyoscope and additional home reinforcement was prescribed in the same period of time.

    Procedure: using three diopter over-minus lenses and a base out prism

Interventions

  • Proceduretrained to do the pencil push-ups procedure

    15 minutes per day, five days a week

  • Procedureusing a major amblyoscope twice weekly with additional home orthoptic therapy

    60 minutes of orthoptic therapy using a major amblyoscope twice weekly with additional home orthoptic therapy was prescribed.

  • Procedureusing three diopter over-minus lenses and a base out prism

    For the augmented office-based vision orthoptic therapy (AOBVOT) group, orthoptic exercises using three diopter over-minus lenses and a base out prism, in addition to major amblyoscope and additional home reinforcement was prescribed in the same period of time.

06

What researchers measure

Primary outcomes

  1. symptomatic convergence insufficiency

    A symptomatic score was an average score of 16 or higher on the CISS(conv-insuff-sympt-scove)

    Time frame: one month

07

Study locations

1 of 1 sites recruiting
  • Ophthalmic Research Center
    Tehran, Iran, Islamic Republic of
    Recruiting
08

References and documents

Publications

  • Scheiman M, Kulp MT, Cotter SA, Lawrenson JG, Wang L, Li T. Interventions for convergence insufficiency: a network meta-analysis. Cochrane Database Syst Rev. 2020 Dec 2;12(12):CD006768. doi: 10.1002/14651858.CD006768.pub3. PubMed 33263359 ↗
09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Feb 2018; primary completion for Jul 2018, 5 months later.

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

Registered
Dec 12, 2017
First posted
Feb 13, 2018
StartEst.
Feb 2018
Primary completionEst.
Jul 2018
CompletionEst.
Dec 2018
Last update
Feb 13, 2018
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 Feb 13, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03431454
Responsible party
Zahra Rabbani Khah (Shahid Beheshti University of Medical Sciences, Shahid Beheshti University of Medical Sciences) — Principal investigator
First posted
Feb 13, 2018
Start date
Feb 2018 (estimated)
Primary completion
Jul 2018 (estimated)
Completion
Dec 2018 (estimated)
Last update
Feb 13, 2018

Study contacts

Maryam Aletaha, MD
Contact
labbafi@hotmail.com
9822591616

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Dec 2017. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion