Comparison of Three Vision Therapy Approaches for Convergence InsufficiencyPhase 2NCT03431454
Comparison of Three Vision Therapy Approaches for Convergence Insufficiency
A Phase 2 study testing trained to do the pencil push-ups procedure, using a major amblyoscope twice weekly with additional home orthoptic therapy and using three diopter over-minus lenses and a base out prism in people with Comparison of Three Vision Therapy Approaches for Convergence Insufficiency, run by Shahid Beheshti University of Medical Sciences at 1 site in Iran.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Comparison of Three Vision Therapy Approaches for Convergence Insufficiency
- What is being tested?
- trained to do the pencil push-ups procedure, using a major amblyoscope twice weekly with additional home orthoptic therapy and using three diopter over-minus lenses and a base out prism
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteIran
- Study dates
- Feb 2018to Dec 2018
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 35 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Iran1 site, 1 recruiting
- Recruiting
Ophthalmic Research Center
Tehran
Maryam Aletaha, MD, 9822591616, labbafi@hotmail.com
About this study
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.
- Being tested
- trained to do the pencil push-ups procedure, using a major amblyoscope twice weekly with additional home orthoptic therapy, using three diopter over-minus lenses and a base out prism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
trained to do the pencil push-ups procedureProcedure or surgery
15 minutes per day, five days a week
using a major amblyoscope twice weekly with additional home orthoptic therapyProcedure or surgery
60 minutes of orthoptic therapy using a major amblyoscope twice weekly with additional home orthoptic therapy was prescribed.
using three diopter over-minus lenses and a base out prismProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| home-based vision orthoptic therapy (HBVOT) group | Active comparator | 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 Receives: Procedure: trained to do the pencil push-ups procedure |
| office-based vision orthoptic therapy (OBVOT) group | Active comparator | 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 Receives: Procedure: using a major amblyoscope twice weekly with additional home orthoptic therapy |
| augmented office-based vision orthoptic therapy (AOBVOT) group | Active comparator | 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. Receives: Procedure: using three diopter over-minus lenses and a base out prism |
What is being measured
The primary outcome is the main question the study is designed to answer.
symptomatic convergence insufficiency
A symptomatic score was an average score of 16 or higher on the CISS(conv-insuff-sympt-scove)
Measured: one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2018
- Study startFeb 2018 (estimated)
- Primary completionJul 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Comparison of Three Vision Therapy Approaches for Convergence InsufficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shahid Beheshti University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zahra Rabbani Khah, Shahid Beheshti University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03431454
- Sponsor's protocol ID
- 92149
- Status last verified
- Dec 2017
- First submitted
- 12 Dec 2017
- Last updated
- 13 Feb 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Three Vision Therapy Approaches for Convergence Insufficiency
- ClinicalTrials.gov ID
- NCT03431454
- Acronym / sponsor ID
- 92149
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Shahid Beheshti University of Medical SciencesUniversity, hospital or other
- Study start
- Feb 2018 (estimated)
- Primary completion
- Jul 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 13 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| home-based vision orthoptic therapy (HBVOT) group | Active comparator | Procedure: trained to do the pencil push-ups procedureIn 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 |
| office-based vision orthoptic therapy (OBVOT) group | Active comparator | Procedure: using a major amblyoscope twice weekly with additional home orthoptic therapyIn 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 |
| augmented office-based vision orthoptic therapy (AOBVOT) group | Active comparator | Procedure: using three diopter over-minus lenses and a base out prismFor 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. |
Who may qualify
- Ages
- 15 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| trained to do the pencil push-ups procedure15 minutes per day, five days a week | Procedure or surgery | home-based vision orthoptic therapy (HBVOT) group |
| using a major amblyoscope twice weekly with additional home orthoptic therapy60 minutes of orthoptic therapy using a major amblyoscope twice weekly with additional home orthoptic therapy was prescribed. | Procedure or surgery | office-based vision orthoptic therapy (OBVOT) group |
| using three diopter over-minus lenses and a base out prismFor 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 or surgery | augmented office-based vision orthoptic therapy (AOBVOT) group |
Primary outcome
symptomatic convergence insufficiency
Time frame: one month
A symptomatic score was an average score of 16 or higher on the CISS(conv-insuff-sympt-scove)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2018.
- Derived from this study: PubMed 33263359Scheiman 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing trained to do the pencil push-ups procedure, using a major amblyoscope twice weekly with additional home orthoptic therapy and using three diopter over-minus lenses and a base out prism in people with Comparison of Three Vision Therapy Approaches for Convergence Insufficiency, run by Shahid Beheshti University of Medical Sciences at 1 site in Iran.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Maryam Aletaha, MD (9822591616, labbafi@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
symptomatic convergence insufficiency (time frame: one month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03431454, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2018.