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NCT Number: NCT06913400

Progression of Stereopsis Recovery in Strabismic Patients: A One-Month and Three-Month Post-Surgery Evaluation

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Strabismic Amblyopia, Bilateral Amblyopia Brain Diseases Central Nervous System Diseases Eye Diseases Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms Vision Disorders

Age range

5 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CENUM Center Mayo Hospital Rd, Anarkali Bazaar

Lahore, Punjab Province, 54000, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Stereopsis Recovery

Combination Product

This prospective longitudinal observational study aims to assess stereopsis recovery in strabismic patients at one month and three months post-corrective surgery

Primary outcomes

  1. Titmus fly test

    Time frame: 12 Months

    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.

Sponsors and collaborators

Lead sponsor

Superior University

Other

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Apr 6, 2025
Registry last updated
Apr 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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