AmblyopiaNCT02113709
Determining the Efficacy of Full-time Occlusion Therapy in Severe Amblyopia at Different Ages
A study testing Occlusion therapy by Eye Patch and Occlusion therapy in people with Amblyopia and Strabismus, run by Mughal Eye Trust Hospital at 1 site in Pakistan.
Trial summary
Objective: To find out how much visual improvement is possible in severe amblyopia using full-time occlusion therapy with an eye patch and to see if improvement is influenced by the patient's age. Read more about this study
- Who is it for?
- Ages 3 years and older
- Conditions the study is for
- Amblyopia, Strabismus
- What is being tested?
- Occlusion therapy by Eye Patch and Occlusion therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 115 participants
- Where
- 1 sitePakistan
- Study dates
- Jan 2010to Jun 2014
- Phase
- Interventional
- 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 3 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- a visual acuity of 6/60 or 0.1-0.2 ETDRS in one eye and 6/6 or 1.0 ETDRS in the good eye
- strabismic amblyopia
- patients of any age were included.
Who cannot join
- structural damage to the eye (organic amblyopia)
- ametropic amblyopia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Determining the Efficacy of Full-time Occlusion Therapy in Severe Amblyopia at All Ages
Objective: To find out how much visual improvement is possible in severe amblyopia using full-time occlusion therapy with an eye patch and to see if improvement is influenced by the patient's age.
Methods: An interventional clinical trial of 115 consecutive cases with unilateral, severe amblyopia was conducted at a tertiary referral center from Jan 2010 to Oct 2012. Patients were divided into three age groups: 3-7 years (n= 38), 8-12 years (n=41), 13-35 years (n=36). After a complete ophthalmological examination by a single ophthalmologist, cases with organic visual loss were excluded; cases with previous part-time occlusion therapy that had failed were included in the study. Patients were given optimal refractive correction for a month, followed by full-time occlusion therapy along with near visual activities for 3-4 hours/day. The therapy was continued until maximum visual recovery was achieved (6/6 Snellen's). Therapy was gradually reduced and stopped. Patients were followed-up regularly for the next 18 months.
Read the detailed description
Amblyopia, ('blunt vision' in Ancient Greek), also known as lazy eye, is a visual deficiency in an eye that is otherwise physically normal, or that is greater than would be expected from any structural abnormalities of the eye. There are unsubstantiated beliefs that it is more difficult to treat amblyopia in older age groups, that children that have already received failed amblyopia therapy do not respond to treatment and that full-time occlusion therapy may result in occlusion (disuse) amblyopia of the good eye. The aim of this study was to assess whether these beliefs are true. Materials and methods This was a prospective, interventional clinical trial of 115 consecutive cases with unilateral, severe amblyopia conducted at a tertiary referral center in Lahore, Pakistan, from January 2010 to October 2012. Eligibility criteria included an age of over three years, visual acuity in the amblyopic eye from 6/60 Snellen's or even counting fingers only, visual acuity in the sound eye of 6/6. A complete ophthalmic examination was performed by only one ophthalmologist (SI). This included examining the fixation pattern of both eyes, presence or absence of a phoria or a tropia by a cover-uncover test, fundus examination and color vision using Ishihara color plates. Any case with an organic cause for visual loss was excluded from the study after a thorough ophthalmological examination. Assessment of visual acuity of either eye for both near and distance acuity (Snellen's and ETDRS charts) refraction and Best Corrected Visual Acuity (BCVA) was performed by a trained optician who was masked to the study and patient's demographics.
- Conditions
- Amblyopia, Strabismus
- Being tested
- Occlusion therapy by Eye Patch, Occlusion therapy
- Keywords
- Amblyopia, Strabismus, Occlusion therapy, Visual improvement
- Medical subject headings
- Amblyopia, Strabismus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Occlusion therapy by Eye PatchDevice
The good eye was occluded by a stick-on eye patch to stimulate the amblyopic eye and its neural connections to learn to see again.
Occlusion therapyDevice
Also called eye patch (commercially pre-packed)
To see how much improvement in visual acuity occurs by full-time occlusion therapy.
| Study group | Role | What they receive |
|---|---|---|
| Visual improvement | Experimental | To see how efficiently visual improvement occurs by Full-time Occlusion therapy with an eye patch in severe amblyopia. Receives: Device: Occlusion therapy by Eye Patch; Device: Occlusion therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Acuity improvement
Full-time occlusion therapy of good eye was performed for 2-3 months while closely monitoring the vision of both the good and the amblyopic eye. Vision was assessed by EDTRS Charts as well as Snellen's Chart.
Measured: 3 months
Secondary outcomes (1)
improvement in stereopsis
as equal visual acuity is attained by both eyes, the stereopsis also improves. It was assessed by satandardized TNO plates with the patient wearing polarized glasses over their own corrective spectacles.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2014 (estimated)
- Study startJan 2010
- Primary completionOct 2012
- Study completionJun 2014 (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.
- 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 115 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mughal Eye Trust Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Sameera Irfan, Mughal Eye Trust Hospital
- Investigators
- Sameera Irfan, FRCS, Principal investigator, Mughal Eye Trust Hospital, Lahore, Pakistan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02113709
- Sponsor's protocol ID
- SIrfanMEHT
- Status last verified
- Apr 2014
- First submitted
- 29 Mar 2014
- Last updated
- 15 Apr 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determining the Efficacy of Full-time Occlusion Therapy in Severe Amblyopia at All Ages
- ClinicalTrials.gov ID
- NCT02113709
- Acronym / sponsor ID
- SIrfanMEHT
- Conditions
- Amblyopia, Strabismus
- Keywords
- Amblyopia, Strabismus, Occlusion therapy, Visual improvement
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 115 participants (actual)
- Lead sponsor
- Mughal Eye Trust HospitalUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Oct 2012 (actual)
- Study completion
- Jun 2014 (estimated)
- First posted
- 15 Apr 2014 (estimated)
- 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.
Objective: To find out how much visual improvement is possible in severe amblyopia using full-time occlusion therapy with an eye patch and to see if improvement is influenced by the patient's age.
Methods: An interventional clinical trial of 115 consecutive cases with unilateral, severe amblyopia was conducted at a tertiary referral center from Jan 2010 to Oct 2012. Patients were divided into three age groups: 3-7 years (n= 38), 8-12 years (n=41), 13-35 years (n=36). After a complete ophthalmological examination by a single ophthalmologist, cases with organic visual loss were excluded; cases with previous part-time occlusion therapy that had failed were included in the study. Patients were given optimal refractive correction for a month, followed by full-time occlusion therapy along with near visual activities for 3-4 hours/day. The therapy was continued until maximum visual recovery was achieved (6/6 Snellen's). Therapy was gradually reduced and stopped. Patients were followed-up regularly for the next 18 months.
Detailed description
Amblyopia, ('blunt vision' in Ancient Greek), also known as lazy eye, is a visual deficiency in an eye that is otherwise physically normal, or that is greater than would be expected from any structural abnormalities of the eye. There are unsubstantiated beliefs that it is more difficult to treat amblyopia in older age groups, that children that have already received failed amblyopia therapy do not respond to treatment and that full-time occlusion therapy may result in occlusion (disuse) amblyopia of the good eye. The aim of this study was to assess whether these beliefs are true. Materials and methods This was a prospective, interventional clinical trial of 115 consecutive cases with unilateral, severe amblyopia conducted at a tertiary referral center in Lahore, Pakistan, from January 2010 to October 2012. Eligibility criteria included an age of over three years, visual acuity in the amblyopic eye from 6/60 Snellen's or even counting fingers only, visual acuity in the sound eye of 6/6. A complete ophthalmic examination was performed by only one ophthalmologist (SI). This included examining the fixation pattern of both eyes, presence or absence of a phoria or a tropia by a cover-uncover test, fundus examination and color vision using Ishihara color plates. Any case with an organic cause for visual loss was excluded from the study after a thorough ophthalmological examination. Assessment of visual acuity of either eye for both near and distance acuity (Snellen's and ETDRS charts) refraction and Best Corrected Visual Acuity (BCVA) was performed by a trained optician who was masked to the study and patient's demographics.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Visual improvement | Experimental | Device: Occlusion therapy by Eye Patch, Device: Occlusion therapyTo see how efficiently visual improvement occurs by Full-time Occlusion therapy with an eye patch in severe amblyopia. |
Who may qualify
- Ages
- 3 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- a visual acuity of 6/60 or 0.1-0.2 ETDRS in one eye and 6/6 or 1.0 ETDRS in the good eye
- strabismic amblyopia
- patients of any age were included.
Key exclusion criteria (2 listed)
- structural damage to the eye (organic amblyopia)
- ametropic amblyopia
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 |
|---|---|---|
| Occlusion therapy by Eye PatchThe good eye was occluded by a stick-on eye patch to stimulate the amblyopic eye and its neural connections to learn to see again. | Device | Visual improvement |
| Occlusion therapyAlso: eye patch (commercially pre-packed)To see how much improvement in visual acuity occurs by full-time occlusion therapy. | Device | Visual improvement |
Primary outcome
Visual Acuity improvement
Time frame: 3 months
Full-time occlusion therapy of good eye was performed for 2-3 months while closely monitoring the vision of both the good and the amblyopic eye. Vision was assessed by EDTRS Charts as well as Snellen's Chart.
1 secondary outcome
improvement in stereopsis
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2014.
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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.
Sameera Irfan, FRCS principal investigator
Mughal Eye Trust Hospital, Lahore, Pakistan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Occlusion therapy by Eye Patch and Occlusion therapy in people with Amblyopia and Strabismus, run by Mughal Eye Trust Hospital 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 3 inclusion and 2 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 15 Apr 2014. 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?
Results are not available in the source record.
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?
Visual Acuity improvement (time frame: 3 months). 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 15 Apr 2014.