Strabismic Amblyopia, BilateralNCT06913400
Progression of Stereopsis Recovery in Strabismic Patients: A One-Month and Three-Month Post-Surgery Evaluation
An observational study of Strabismic Amblyopia, Bilateral, run by Superior University at 1 site in Pakistan.
Trial summary
This prospective longitudinal observational study aims to assess stereopsis recovery in strabismic patients at one month and three months post-corrective surgery. The study will be conducted at Mayo Hospital, Lahore, and Sajjad Eye Center, Burewala, with a sample size of 34 using a purposive sampling technique. Read more about this study
- Who is it for?
- Ages 5 years and older
- Conditions the study is for
- Strabismic Amblyopia, Bilateral
- What is being tested?
- Stereopsis Recovery
- How many people
- 34 participants
- Where
- 1 sitePakistan
- Study dates
- 20 Mar 2025to 20 Feb 2026
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: This prospective longitudinal observational study aims to assess stereopsis recovery in strabismic patients at one month and three months post-corrective surgery. The study will be conducted at Mayo Hospital, Lahore, and Sajjad Eye Center, Burewala, with a sample size of 34 using a purposive sampling technique. Eligible participants include patients aged ≥5 years undergoing strabismus surgery for esotropia, exotropia, or vertical deviations, with best-corrected visual acuity (BCVA) of 6/12 in both eyes.
Who may be able to join
- Patients (≥5 years and adults) undergoing strabismus surgery for: esotropia, exotropia, vertical deviations (hypertropia or hypotropia)
- Best corrected visual acuity (BCVA) of 6/12 in both eyes
- Willingness to attend follow-up visits at 1 month and 3 months post-surgery.8
Who cannot join
- History of previous strabismus surgery
- Amblyopia
- Neurological and systemic conditions affecting vision
- Uncontrolled nystagmus and sensory strabismus
- Patients unable to complete stereopsis testing due to cognitive or physical limit
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
CENUM Center Mayo Hospital Rd, Anarkali Bazaar
Lahore, Punjab Province, 54000
About this study
This prospective longitudinal observational study aims to assess stereopsis recovery in strabismic patients at one month and three months post-corrective surgery. The study will be conducted at Mayo Hospital, Lahore, and Sajjad Eye Center, Burewala, with a sample size of 34 using a purposive sampling technique. Eligible participants include patients aged ≥5 years undergoing strabismus surgery for esotropia, exotropia, or vertical deviations, with best-corrected visual acuity (BCVA) of 6/12 in both eyes. Patients with previous strabismus surgery, amblyopia, neurological conditions, or sensory strabismus will be excluded.
Read the detailed description
Baseline assessments include visual acuity (Snellen Chart), ocular alignment (cover-uncover and prism cover tests), and stereopsis (Titmus Fly Test). The same tests will be repeated one month and three months post-surgery to evaluate changes. The study aims to determine whether strabismus surgery enhances binocular function and stereopsis, helping guide future treatment strategies. Data will be analyzed using paired t-tests to assess differences over time.
- Conditions
- Strabismic Amblyopia, Bilateral
- Being tested
- Stereopsis Recovery
- Medical subject headings
- Amblyopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stereopsis RecoveryCombination product
This prospective longitudinal observational study aims to assess stereopsis recovery in strabismic patients at one month and three months post-corrective surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Titmus fly test
It is a contour stereo test performed at distance of 40cm. the test comprises of 3 sections:
- The housefly which shows large disparities and should be seen in depth by most subjects. Stereoacuity range of Random Dot Butterfly is
- Bottom of lower wing: 1150 sec of arc
- Tip of abdomen: 700 sec of arc
- Top of upper wing: 2000 sec of arc
- There are 3 rows of animals, one animal in each row having a crossed disparity which ranges from 100, 200, 400 secs of arc.
- Circle patterns: this section consists of 9 patterns containing four circles. The disparities of the circles range from 800 to 40 secs of arc.
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 posted6 Apr 2025
- Study start20 Mar 2025
- Primary completion20 Jun 2025 (estimated)
- Study completion20 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Strabismic Amblyopia, BilateralStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 34 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
- NCT06913400
- Sponsor's protocol ID
- MSRSW/Batch-Fall23/793
- Status last verified
- Mar 2025
- First submitted
- 29 Mar 2025
- Last updated
- 6 Apr 2025
- 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 6 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Progression of Stereopsis Recovery in Strabismic Patients: A One-Month and Three-Month Post-Surgery Evaluation
- ClinicalTrials.gov ID
- NCT06913400
- Acronym / sponsor ID
- MSRSW/Batch-Fall23/793
- Conditions
- Strabismic Amblyopia, Bilateral
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Superior UniversityUniversity, hospital or other
- Study start
- 20 Mar 2025 (actual)
- Primary completion
- 20 Jun 2025 (estimated)
- Study completion
- 20 Feb 2026 (estimated)
- First posted
- 6 Apr 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.
This prospective longitudinal observational study aims to assess stereopsis recovery in strabismic patients at one month and three months post-corrective surgery. The study will be conducted at Mayo Hospital, Lahore, and Sajjad Eye Center, Burewala, with a sample size of 34 using a purposive sampling technique. Eligible participants include patients aged ≥5 years undergoing strabismus surgery for esotropia, exotropia, or vertical deviations, with best-corrected visual acuity (BCVA) of 6/12 in both eyes. Patients with previous strabismus surgery, amblyopia, neurological conditions, or sensory strabismus will be excluded.
Detailed description
Baseline assessments include visual acuity (Snellen Chart), ocular alignment (cover-uncover and prism cover tests), and stereopsis (Titmus Fly Test). The same tests will be repeated one month and three months post-surgery to evaluate changes. The study aims to determine whether strabismus surgery enhances binocular function and stereopsis, helping guide future treatment strategies. Data will be analyzed using paired t-tests to assess differences over time.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 5 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- This prospective longitudinal observational study aims to assess stereopsis recovery in strabismic patients at one month and three months post-corrective surgery. The study will be conducted at Mayo Hospital, Lahore, and Sajjad Eye Center, Burewala, with a sample size of 34 using a purposive sampling technique. Eligible participants include patients aged ≥5 years undergoing strabismus surgery for esotropia, exotropia, or vertical deviations, with best-corrected visual acuity (BCVA) of 6/12 in both eyes.
Key inclusion criteria (3 listed)
- Patients (≥5 years and adults) undergoing strabismus surgery for: esotropia, exotropia, vertical deviations (hypertropia or hypotropia)
- Best corrected visual acuity (BCVA) of 6/12 in both eyes
- Willingness to attend follow-up visits at 1 month and 3 months post-surgery.8
Key exclusion criteria (5 listed)
- History of previous strabismus surgery
- Amblyopia
- Neurological and systemic conditions affecting vision
- Uncontrolled nystagmus and sensory strabismus
- Patients unable to complete stereopsis testing due to cognitive or physical limit
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 |
|---|---|---|
| Stereopsis RecoveryThis prospective longitudinal observational study aims to assess stereopsis recovery in strabismic patients at one month and three months post-corrective surgery | Combination product | – |
Primary outcome
Titmus fly test
Time frame: 12 Months
It is a contour stereo test performed at distance of 40cm. the test comprises of 3 sections: 1. The housefly which shows large disparities and should be seen in depth by most subjects. Stereoacuity range of Random Dot Butterfly is * Bottom of lower wing: 1150 sec of arc * Tip of abdomen: 700 sec of arc * Top of upper wing: 2000 sec of arc 2. There are 3 rows of animals, one animal in each row having a crossed disparity which ranges from 100, 200, 400 secs of arc. 3. Circle patterns: this section consists of 9 patterns containing four circles. The disparities of the circles range from 800 to 40 secs of arc.
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 6 Apr 2025.
- Individual participant dataSharing planned: No
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?
An observational study of Strabismic Amblyopia, Bilateral, 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 3 inclusion and 5 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 6 Apr 2025. 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?
Titmus fly test (time frame: 12 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 6 Apr 2025.