AmblyopiaNCT07294599
Morning Versus Evening Patching in Childhood Amblyopia
A study testing eye-patching in people with Amblyopia, run by Yarmouk University at 2 sites in Jordan.
Trial summary
To determine whether the time of day at which daily occlusion therapy is administered-morning, with 2 hours of patching completed within 07:00-10:00, versus evening, with 2 hours completed within 17:00-20:00-affects visual-acuity improvement in the amblyopic eye in children with unilateral amblyopia. Read more about this study
- Who is it for?
- Ages 4 to 8 years
- Conditions the study is for
- Amblyopia
- What is being tested?
- eye-patching
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 2 sitesJordan
- Study dates
- 14 Dec 2025to 1 Aug 2026
- 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 4 to 8 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age: 4-8 years.
- Unilateral amblyopia.
- Amblyopic-eye BCVA decimal 0.17-0.67 (≈ 6/36-6/9).
- Fellow-eye BCVA ≥ 0.80 decimal (≈ 6/7.5 or better).
- Amblyopia type: refractive-dominant or strabismic/mixed.
- Parent/guardian consent obtained.
Who cannot join
- Bilateral amblyopia.
- Sensory-deprivation amblyopia (e.g., due to congenital cataract, ptosis, corneal opacity).
- Ocular surgery within the past 6 months, or planned surgery during study.
- Likely poor adherence (e.g., due to social, logistic, or family constraints).
Trial locations and contacts
2 sites in 1 country.
Jordan2 sites
Irbid Medical Consultation Center
Irbid, Irbid Governorate, 21163
Princess Basma teaching hospital
Irbid, Irbid Governorate, 21163
About this study
Official title: Morning Versus Evening Patching in Childhood Amblyopia-A Randomized Clinical Trial
To determine whether the time of day at which daily occlusion therapy is administered-morning, with 2 hours of patching completed within 07:00-10:00, versus evening, with 2 hours completed within 17:00-20:00-affects visual-acuity improvement in the amblyopic eye in children with unilateral amblyopia.
Rationale:
While occlusion therapy remains the mainstay for treatment of childhood amblyopia, existing trials have focused on patching duration, not on the timing of occlusion. Diurnal or chronobiological factors - such as fluctuations in neuroplasticity, attention, compliance, or visual demand during the day - may influence the efficacy of patching. Understanding whether timing matters could help optimize occlusion therapy, improve outcomes, and reduce treatment burden.
Read the detailed description
Study Type: Prospective, randomized, parallel-group clinical trial.
Participants: Children aged 4-8 years with unilateral amblyopia; amblyopic-eye BCVA between 0.17-0.67 decimal (≈ 6/36-6/9); fellow-eye BCVA ≥ 0.80 decimal; refractive-dominant or strabismic/mixed amblyopia. Parental/guardian consent required.
Randomization \& Stratification: Participants randomized 1:1 to "Morning patching" vs "Evening patching" arms. Stratified by age (4-<6 vs >=6-8), baseline visual acuity or amblyopia severity (moderate 6/36-<6/12 vs mild 6/12-6/9), and amblyopia type (refractive-dominant vs strabismic/mixed) - to ensure balance across key prognostic variables.
Intervention: Participants received daily occlusion of the fellow eye for 2 hours within the assigned treatment window: 07:00-10:00 for the morning group and 17:00-20:00 for the evening group. Near-vision activities, such as reading, puzzles, or coloring, were encouraged during patching but were not formally quantified. Caregivers recorded the start time, end time, and duration of each patching session in a daily diary. Missed weekday patching could be made up on weekends according to the study protocol. Spectacle correction, when prescribed, was maintained throughout the study.
Follow-up / Assessments:
Baseline exam (BCVA both eyes, refraction, ocular alignment/strabismus assessment, anterior and posterior segment exam, stereoacuity, instructions on patching/adherence, randomization).
Midpoint follow-up at 3 months (BCVA, adherence, adverse events. Telehealth acceptable if in-person not possible.).
Final follow-up at 6 months (BCVA (primary endpoint), stereoacuity, ocular alignment/strabismus assessment, anterior segment exam, adherence data review, adverse events, patching compliance summary.).
Primary Outcome: Change in best-corrected visual acuity (BCVA) of the amblyopic eye from baseline to month 6.
Secondary Outcomes: Stereoacuity, caregiver-reported patching adherence within the assigned treatment window, and the proportion of participants achieving at least a 0.20 logMAR improvement from baseline to Month 6.
Statistical Approach: Analysis of covariance (ANCOVA) comparing mean change in BCVA between arms, adjusting for baseline VA and stratification factors. Subgroup analyses by amblyopia type, baseline severity, age group.
Sample Size and Power: Assuming a clinically meaningful between-group difference of 0.12 logMAR, a common standard deviation of 0.18 logMAR, a two-sided alpha of 0.05, and 80% power, 37 evaluable participants per group were required. The target enrollment was increased to 42 participants per group, for a total of 84, to allow for attrition or unavailable Month-6 outcomes.
Duration \& Timeline:
Each participant will be followed for 6 months of daily patching. The total study duration (from first enrollment to last follow-up) will depend on recruitment rate; estimated duration ~ 7-9 months including recruitment, follow-up, data cleaning, and analysis.
Significance \& Expected Impact:
If timing of occlusion influences visual outcome, this could refine occlusion therapy recommendations - potentially improving efficacy, adherence, and convenience for patients and families. The trial may identify a more effective or practical patching schedule, thereby contributing to evidence-based amblyopia management.
- Conditions
- Amblyopia
- Being tested
- eye-patching
- Keywords
- Morning patching, Evening patching, Amblyopia, Clinical trial, Strabismus, Anisometropia
- Medical subject headings
- Amblyopia, Strabismus, Anisometropia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
eye-patchingBehavioural
Also called occlusion therapy
is a non-invasive treatment for Amblyopia ("lazy eye") in children. It involves covering (patching) the stronger, "good" eye so that the weaker (amblyopic) eye is forced to work. This encourages the brain to rely on the amblyopic eye, helping to strengthen its visual pathways.
| Study group | Role | What they receive |
|---|---|---|
| Morning patching | Experimental | Participants patched the fellow eye for 2 hours daily within the morning window of 07:00 to 10:00 for 6 months.
During patching: child is encouraged to perform near-vision activities (e.g. reading, puzzles, coloring).
Duration: 6 months (unless withdrawal criteria met). Receives: Behavioral: eye-patching |
| Evening patching | Experimental | Participants patched the fellow eye for 2 hours daily within the evening window of 17:00 to 20:00 for 6 months.
During patching: same near-vision tasks as Arm 1.
Duration: 6 months (unless withdrawal criteria met). Receives: Behavioral: eye-patching |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in best-corrected visual acuity (BCVA) of the amblyopic eye
Change in best-corrected visual acuity (BCVA) of the amblyopic eye from baseline to month 6, measured using a standardized logMAR (crowded) chart under full refractive correction, by a masked examiner.
Measured: Baseline to Month 6
Secondary outcomes (3)
Adherence percentage reported by caregiver
For each participant, adherence was calculated as the cumulative patching time recorded within the assigned morning or evening treatment window divided by the cumulative prescribed patching time over the 6-month treatment period, expressed as a percentage. Higher percentages indicate greater adherence.
Measured: Baseline through 6 months
Change From Baseline in Stereoacuity at Month 6
Stereoacuity was assesed using the titmus fly test and recorded in seconds of arc
Measured: Baseline through month 6
At least 2-line improvement
Participants with a reduction of at least 0.20 logMAR from baseline to Month 6 were classified as achieving at least a 2-line improvement.
Measured: Baseline and Month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2025
- Study start14 Dec 2025
- Primary completion1 Aug 2026
- Study completion1 Aug 2026
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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Intervention model: Parallel-group randomized trial. Children with unilateral amblyopia were randomized 1:1 to morning patching, consisting of 2 hours daily within 07:00-10:00, or evening patching, consisting of 2 hours daily within 17:00-20:00. Participants remained in their assigned group for 6 months. Near-vision activities were encouraged during patching. Outcomes were assessed at baseline, Month 3, and Month 6. Randomization was stratified by age group, baseline amblyopic-eye BCVA category, and amblyopia type.⁷
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yarmouk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rami Alomari, Yarmouk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07294599
- Sponsor's protocol ID
- IRB/2025/318
- Status last verified
- Aug 2026
- First submitted
- 8 Dec 2025
- Last updated
- 4 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Morning Versus Evening Patching in Childhood Amblyopia-A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07294599
- Acronym / sponsor ID
- IRB/2025/318
- Conditions
- Amblyopia
- Keywords
- Morning patching, Evening patching, Amblyopia, Clinical trial, Strabismus, Anisometropia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Yarmouk UniversityUniversity, hospital or other
- Study start
- 14 Dec 2025 (actual)
- Primary completion
- 1 Aug 2026 (actual)
- Study completion
- 1 Aug 2026 (actual)
- First posted
- 19 Dec 2025 (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.
To determine whether the time of day at which daily occlusion therapy is administered-morning, with 2 hours of patching completed within 07:00-10:00, versus evening, with 2 hours completed within 17:00-20:00-affects visual-acuity improvement in the amblyopic eye in children with unilateral amblyopia.
Rationale:
While occlusion therapy remains the mainstay for treatment of childhood amblyopia, existing trials have focused on patching duration, not on the timing of occlusion. Diurnal or chronobiological factors - such as fluctuations in neuroplasticity, attention, compliance, or visual demand during the day - may influence the efficacy of patching. Understanding whether timing matters could help optimize occlusion therapy, improve outcomes, and reduce treatment burden.
Detailed description
Study Type: Prospective, randomized, parallel-group clinical trial.
Participants: Children aged 4-8 years with unilateral amblyopia; amblyopic-eye BCVA between 0.17-0.67 decimal (≈ 6/36-6/9); fellow-eye BCVA ≥ 0.80 decimal; refractive-dominant or strabismic/mixed amblyopia. Parental/guardian consent required.
Randomization \& Stratification: Participants randomized 1:1 to "Morning patching" vs "Evening patching" arms. Stratified by age (4-<6 vs >=6-8), baseline visual acuity or amblyopia severity (moderate 6/36-<6/12 vs mild 6/12-6/9), and amblyopia type (refractive-dominant vs strabismic/mixed) - to ensure balance across key prognostic variables.
Intervention: Participants received daily occlusion of the fellow eye for 2 hours within the assigned treatment window: 07:00-10:00 for the morning group and 17:00-20:00 for the evening group. Near-vision activities, such as reading, puzzles, or coloring, were encouraged during patching but were not formally quantified. Caregivers recorded the start time, end time, and duration of each patching session in a daily diary. Missed weekday patching could be made up on weekends according to the study protocol. Spectacle correction, when prescribed, was maintained throughout the study.
Follow-up / Assessments:
Baseline exam (BCVA both eyes, refraction, ocular alignment/strabismus assessment, anterior and posterior segment exam, stereoacuity, instructions on patching/adherence, randomization).
Midpoint follow-up at 3 months (BCVA, adherence, adverse events. Telehealth acceptable if in-person not possible.).
Final follow-up at 6 months (BCVA (primary endpoint), stereoacuity, ocular alignment/strabismus assessment, anterior segment exam, adherence data review, adverse events, patching compliance summary.).
Primary Outcome: Change in best-corrected visual acuity (BCVA) of the amblyopic eye from baseline to month 6.
Secondary Outcomes: Stereoacuity, caregiver-reported patching adherence within the assigned treatment window, and the proportion of participants achieving at least a 0.20 logMAR improvement from baseline to Month 6.
Statistical Approach: Analysis of covariance (ANCOVA) comparing mean change in BCVA between arms, adjusting for baseline VA and stratification factors. Subgroup analyses by amblyopia type, baseline severity, age group.
Sample Size and Power: Assuming a clinically meaningful between-group difference of 0.12 logMAR, a common standard deviation of 0.18 logMAR, a two-sided alpha of 0.05, and 80% power, 37 evaluable participants per group were required. The target enrollment was increased to 42 participants per group, for a total of 84, to allow for attrition or unavailable Month-6 outcomes.
Duration \& Timeline:
Each participant will be followed for 6 months of daily patching. The total study duration (from first enrollment to last follow-up) will depend on recruitment rate; estimated duration ~ 7-9 months including recruitment, follow-up, data cleaning, and analysis.
Significance \& Expected Impact:
If timing of occlusion influences visual outcome, this could refine occlusion therapy recommendations - potentially improving efficacy, adherence, and convenience for patients and families. The trial may identify a more effective or practical patching schedule, thereby contributing to evidence-based amblyopia management.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Intervention model: Parallel-group randomized trial. Children with unilateral amblyopia were randomized 1:1 to morning patching, consisting of 2 hours daily within 07:00-10:00, or evening patching, consisting of 2 hours daily within 17:00-20:00. Participants remained in their assigned group for 6 months. Near-vision activities were encouraged during patching. Outcomes were assessed at baseline, Month 3, and Month 6. Randomization was stratified by age group, baseline amblyopic-eye BCVA category, and amblyopia type.⁷
| Arm | Type | Receives |
|---|---|---|
| Morning patching | Experimental | Behavioral: eye-patchingParticipants patched the fellow eye for 2 hours daily within the morning window of 07:00 to 10:00 for 6 months. During patching: child is encouraged to perform near-vision activities (e.g. reading, puzzles, coloring). Duration: 6 months (unless withdrawal criteria met). |
| Evening patching | Experimental | Behavioral: eye-patchingParticipants patched the fellow eye for 2 hours daily within the evening window of 17:00 to 20:00 for 6 months. During patching: same near-vision tasks as Arm 1. Duration: 6 months (unless withdrawal criteria met). |
Who may qualify
- Ages
- 4 to 8 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Age: 4-8 years.
- Unilateral amblyopia.
- Amblyopic-eye BCVA decimal 0.17-0.67 (≈ 6/36-6/9).
- Fellow-eye BCVA ≥ 0.80 decimal (≈ 6/7.5 or better).
- Amblyopia type: refractive-dominant or strabismic/mixed.
Key exclusion criteria (4 listed)
- Bilateral amblyopia.
- Sensory-deprivation amblyopia (e.g., due to congenital cataract, ptosis, corneal opacity).
- Ocular surgery within the past 6 months, or planned surgery during study.
- Likely poor adherence (e.g., due to social, logistic, or family constraints).
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 |
|---|---|---|
| eye-patchingAlso: occlusion therapyis a non-invasive treatment for Amblyopia ("lazy eye") in children. It involves covering (patching) the stronger, "good" eye so that the weaker (amblyopic) eye is forced to work. This encourages the brain to rely on the amblyopic eye, helping to strengthen its visual pathways. | Behavioural | Evening patching, Morning patching |
Primary outcome
Change in best-corrected visual acuity (BCVA) of the amblyopic eye
Time frame: Baseline to Month 6
Change in best-corrected visual acuity (BCVA) of the amblyopic eye from baseline to month 6, measured using a standardized logMAR (crowded) chart under full refractive correction, by a masked examiner.
3 secondary outcomes
Adherence percentage reported by caregiver
Time frame: Baseline through 6 months
Change From Baseline in Stereoacuity at Month 6
Time frame: Baseline through month 6
At least 2-line improvement
Time frame: Baseline and Month 6
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2026.
- Individual participant dataSharing planned: Undecided
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing eye-patching in people with Amblyopia, run by Yarmouk University at 2 sites in Jordan.
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 6 inclusion and 4 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: finished, as of the sponsor's last update on 4 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Jordan. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in best-corrected visual acuity (BCVA) of the amblyopic eye (time frame: Baseline to Month 6). 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 4 Aug 2026.