Comparing Two Surgical Methods to Prevent Pterygium Regrowth

Evaluation of Conjunctival Rotational Flap Compared to Conjunctival Autograft After Surgical Removal of Primary Pterygium: A Randomized Controlled Trial

This study compares two surgical techniques for preventing the regrowth of a pterygium, a non-cancerous growth on the eye. After surgically removing the pterygium, surgeons will cover the area with either a flap of nearby tissue that is rotated into place (Rotational Flap) or with a free graft of tissue taken from under the upper eyelid (Autograft). The main goal is to see which method is better at preventing the pterygium from growing back over a 6-month period. A total of 342 patients with a primary pterygium will be randomly assigned to one of the two surgical groups.

Study Overview

• Status: Not yet recruiting
• Conditions: Pterygium
• Intervention / Treatment: Procedure: Conjunctival Rotational Flap; Procedure: Conjunctival Autograft

Detailed Description

This is a single-center, prospective, randomized controlled trial to be conducted at the Department of Ophthalmology, Saidu Group of Teaching Hospital, Swat. The study aims to compare the efficacy of the Conjunctival Rotational Flap versus the Conjunctival Autograft in reducing recurrence rates following primary pterygium excision. Adult patients aged 18-60 with primary pterygium will be enrolled. Participants will be randomly allocated into two groups: Group A (Conjunctival Rotational Flap) and Group B (Conjunctival Autograft). The primary outcome measure is the absence of clinical recurrence, defined as fibrovascular tissue crossing ≥ 1 mm onto the cornea, assessed at the 6-month postoperative follow-up visit via slit-lamp examination. Secondary outcomes may include operative time and postoperative complications. Data will be analyzed using SPSS version 23, with a p-value of ≤ 0.05 considered statistically significant.

• Study Type: Interventional
• Enrollment (Estimated): 342
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Muhammad Iqbal, MBBS; Phone Number: +923049208484; Email: Miqbalskt@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• • Age 18-60

  • Either gender
  • Primary pterygium

Exclusion Criteria:

• • Collagen vascular disease

  • Autoimmune disorders
  • Pregnancy
  • Ocular surface infection
  • Previous limbal surgery
  • Recurrent or pseudo-pterygium
  • Ocular trauma
  • Corneal opacity/degeneration'

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Rotational Flap; A hinged conjunctival flap created adjacent to the excision site and rotated to cover the scleral defect while maintaining partial vascular attachment.	Procedure: Conjunctival Rotational Flap; A surgical technique where adjacent conjunctival tissue, remaining partially attached, is rotated to cover the exposed sclera after pterygium excision.; Procedure: Conjunctival Autograft; A surgical technique where a free graft of conjunctiva is harvested from the superior bulbar conjunctiva and sutured or glued over the scleral defect after pterygium excision
Active Comparator: Conjunctival Autograft; A free conjunctival graft harvested from the superior bulbar conjunctiva and transplanted to the scleral bed after pterygium excision.	Procedure: Conjunctival Rotational Flap; A surgical technique where adjacent conjunctival tissue, remaining partially attached, is rotated to cover the exposed sclera after pterygium excision.; Procedure: Conjunctival Autograft; A surgical technique where a free graft of conjunctiva is harvested from the superior bulbar conjunctiva and sutured or glued over the scleral defect after pterygium excision

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pterygium Recurrence Rate	Absence of clinical recurrence, defined as a quiet ocular surface with no fibrovascular regrowth ≥ 1 mm onto the cornea, as measured by slit-lamp examination.	6 months postoperatively

Collaborators and Investigators

• Sponsor: College of Physicians and Surgeons Pakistan

Study record dates

Study Major Dates

• Study Start (Estimated): February 2, 2026
• Primary Completion (Estimated): July 2, 2026
• Study Completion (Estimated): July 2, 2026

Study Registration Dates

• First Submitted: November 30, 2025
• First Submitted That Met QC Criteria: November 30, 2025
• First Posted (Actual): December 11, 2025

Study Record Updates

• Last Update Posted (Actual): December 11, 2025
• Last Update Submitted That Met QC Criteria: November 30, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: Conjunctival Autograft; Conjunctival Rotational Flap; Pterygium Recurrence
• Additional Relevant MeSH Terms: Eye Diseases; Conjunctival Diseases; Pterygium
• Other Study ID Numbers: SGTH-Oph-Pterygium-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No