Preoperative and Postoperative Refractive and Topographic Evaluation in Patients With Primary Pterygium: A Comparison of Conjunctival Autograft and Amniotic Membrane Transplantation
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 78
- Primary Endpoint
- Change in Corneal Topographic Astigmatism
Study Overview
Brief Summary
This study evaluated changes in refractive status and corneal topography before and after surgical treatment of primary pterygium. Patients undergoing pterygium excision were treated with either conjunctival autograft or amniotic membrane transplantation. Visual acuity, refractive error, and corneal topographic parameters were assessed before surgery and after postoperative follow-up to compare the effectiveness of both surgical techniques in restoring corneal optics and improving visual outcomes.
Detailed Description
Primary pterygium is a fibrovascular proliferation of the bulbar conjunctiva that extends onto the cornea and may induce significant refractive and topographic changes, resulting in visual impairment. Surgical excision is the treatment of choice for progressive lesions, with conjunctival autograft (CA) and amniotic membrane transplantation (AMT) representing two widely used techniques.
Patients underwent conjunctival autograft or amniotic membrane transplantation based solely on the treating surgeon's clinical judgment, independently of study participation. The study did not assign surgical interventions. Patients were prospectively followed to compare refractive and corneal topographic outcomes between the two naturally occurring treatment cohorts.
The primary objective was to compare postoperative refractive and topographic changes between the two surgical techniques. Secondary objectives included evaluating changes in visual acuity, corneal curvature, refractive astigmatism, topographic astigmatism, and identifying clinical factors associated with postoperative outcomes.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Adults aged 18 years or older.
- •Diagnosis of primary nasal pterygium in one or both eyes.
- •Pterygium extending at least 1 mm onto the cornea.
- •Underwent primary pterygium excision with either conjunctival autograft (CAG) or amniotic membrane transplantation (AMT).
Exclusion Criteria
- •Corneal scars.
- •Corneal ectatic disorders.
- •History of ocular trauma.
- •Previous ocular surgery.
- •Cicatrizing ocular surface disease.
- •Cataract or any other ocular condition that could affect visual function.
Arms & Interventions
Conjunctival Autograft
Participants with primary pterygium underwent pterygium excision followed by conjunctival autograft transplantation. Postoperative refractive status, visual acuity, and corneal topographic outcomes were evaluated during a 12-month follow-up.
Intervention: Conjunctival Autograft (Procedure)
Amniotic Membrane Transplantation
Participants with primary pterygium underwent pterygium excision followed by amniotic membrane transplantation. Postoperative refractive status, visual acuity, and corneal topographic outcomes were evaluated during a 12-month follow-up.
Intervention: Amniotic Membrane Transplantation (Procedure)
Outcomes
Primary Outcomes
Change in Corneal Topographic Astigmatism
Time Frame: Baseline and 12 months after surgery
Comparison of the change in corneal topographic astigmatism from baseline to 12 months after pterygium excision between conjunctival autograft and amniotic membrane transplantation.
Secondary Outcomes
No secondary outcomes reported