AmblyopiaNCT06739798
Comparison of Binocular Spectacle Prescription Versus Patching Therapy in Refractive Amblyopia Patients
A study testing Exp Group in people with Amblyopia, run by Superior University at 1 site in Pakistan.
Trial summary
This study will examine on Refractive Amblyopia patients, whose amblyopia started due to longstanding uncorrected refractive errors. Read more about this study
- Who is it for?
- Ages 5 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Amblyopia
- What is being tested?
- Exp Group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Apr 2024to 30 Mar 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 5 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Anisometropic amblyopia
- Anisometropia > 1.00 D( difference between eyes in SE)
- Astigmatism >1.50 D
- VA in amblyopic eye 20/40 -20/200(6/12-6/60) or less than 20/200
- VA in the better eye or fellow eye 20/30 (6/9) or better
Who cannot join
- Strabismic amblyopia
- Deprivation amblyopia
- Isoametropic amblyopia
- History of ocular trauma, IOL implant
- Media opacity
- Any ocular/retinal pathology
Show all 9Show fewer
- Optic nerve pathology
- Ptosis
- Any gaze control abnormalities
Trial locations and contacts
1 site in 1 country.
About this study
This study will examine on Refractive Amblyopia patients, whose amblyopia started due to longstanding uncorrected refractive errors.
Read the detailed description
There will be a comparison of two treatment methods i.e. Patching and Binocular Spectacle Prescription used to cure amblyopia patients. In binocular spectacle correction, we will slightly blur the good eye and fully correct the amblyopic eye so that binocular functions stimulate and improve after the treatment. Literature suggests that Patching improve monocular functions but there is no significant improvement in binocular functions.
- Conditions
- Amblyopia
- Being tested
- Exp Group, Control Group
- Medical subject headings
- Amblyopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exp GroupDiagnostic test
Binocular Spectacle prescription are therapeutic tools used to correct refractive errors in visually impaired patients. They improve Visual acuity as well as other visual functions in Amblyopic and visual impairment patients. They stimulate weaker eye to generate visual impulse and stimulate visual cortex to improve stereopsis and fusion.
Control GroupDiagnostic test
Patching therapy is a gold standard tool used world wide to correct visual acuity in amblyopic patients. This tool is used by occluding stronger eye with a patch or bandage or fogging lens and stimulating amblyopic eye to generate visual stimulus to motivate visual cortex.
| Study group | Role | What they receive |
|---|---|---|
| Exp Group | Experimental | Not described Receives: Diagnostic Test: Exp Group |
| Control Group | Active comparator | Not described Receives: Diagnostic Test: Control Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Binocular single vision
it will be measured by Worth 4 Dot test in which patient will see four lights ( two green, one red and one white light) with red and green glasses and both eyes will see at once.
stereopsis: it will be measured grossly by seeing the fly picture at the card and fine stereopsis will be measured by different pictures available on the card. it will be assessed by wearing polarising glasses during test and see the 3D pictures."
Measured: 12 Months
Visual Acuity
it will be assessed monocularly by logMAR visual acuity chart at 4 meter distance.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2024
- Study start1 Apr 2024
- Primary completion1 Sep 2024
- Study completion30 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AmblyopiaStudies of the same condition, open and under way.
- More trials run by Superior UniversityThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Superior University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muhammad Naveed Babur, Superior University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06739798
- Sponsor's protocol ID
- MSRSW/Batch-Fall22/755
- Status last verified
- Dec 2024
- First submitted
- 13 Dec 2024
- Last updated
- 18 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Binocular Spectacle Prescription Versus Patching Therapy in Refractive Amblyopia Patients
- ClinicalTrials.gov ID
- NCT06739798
- Acronym / sponsor ID
- MSRSW/Batch-Fall22/755
- Conditions
- Amblyopia
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Superior UniversityUniversity, hospital or other
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 1 Sep 2024 (actual)
- Study completion
- 30 Mar 2025 (estimated)
- First posted
- 18 Dec 2024 (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.
This study will examine on Refractive Amblyopia patients, whose amblyopia started due to longstanding uncorrected refractive errors.
Detailed description
There will be a comparison of two treatment methods i.e. Patching and Binocular Spectacle Prescription used to cure amblyopia patients. In binocular spectacle correction, we will slightly blur the good eye and fully correct the amblyopic eye so that binocular functions stimulate and improve after the treatment. Literature suggests that Patching improve monocular functions but there is no significant improvement in binocular functions.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exp Group | Experimental | Diagnostic Test: Exp Group |
| Control Group | Active comparator | Diagnostic Test: Control Group |
Who may qualify
- Ages
- 5 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Anisometropic amblyopia
- Anisometropia > 1.00 D( difference between eyes in SE)
- Astigmatism >1.50 D
- VA in amblyopic eye 20/40 -20/200(6/12-6/60) or less than 20/200
- VA in the better eye or fellow eye 20/30 (6/9) or better
Key exclusion criteria (9 listed)
- Strabismic amblyopia
- Deprivation amblyopia
- Isoametropic amblyopia
- History of ocular trauma, IOL implant
- Media opacity
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 |
|---|---|---|
| Exp GroupBinocular Spectacle prescription are therapeutic tools used to correct refractive errors in visually impaired patients. They improve Visual acuity as well as other visual functions in Amblyopic and visual impairment patients. They stimulate weaker eye to generate visual impulse and stimulate visual cortex to improve stereopsis and fusion. | Diagnostic test | Exp Group |
| Control GroupPatching therapy is a gold standard tool used world wide to correct visual acuity in amblyopic patients. This tool is used by occluding stronger eye with a patch or bandage or fogging lens and stimulating amblyopic eye to generate visual stimulus to motivate visual cortex. | Diagnostic test | Control Group |
Primary outcome
Binocular single vision
Time frame: 12 Months
it will be measured by Worth 4 Dot test in which patient will see four lights ( two green, one red and one white light) with red and green glasses and both eyes will see at once. stereopsis: it will be measured grossly by seeing the fly picture at the card and fine stereopsis will be measured by different pictures available on the card. it will be assessed by wearing polarising glasses during test and see the 3D pictures."
Visual Acuity
Time frame: 12 months
it will be assessed monocularly by logMAR visual acuity chart at 4 meter distance.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2024.
- Individual participant dataSharing planned: No
Related trials for Amblyopia
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exp Group in people with Amblyopia, run by Superior University at 1 site in Pakistan.
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 9 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: under way, not looking for participants, as of the sponsor's last update on 18 Dec 2024. 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 Pakistan. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Binocular single vision (time frame: 12 Months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Dec 2024.