Comparing Two Surgical Methods to Prevent Pterygium Regrowth

NCT ID: NCT07277426

Last Updated: 2025-12-11

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 342 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-02-02
• Study Completion Date: 2026-07-02

Brief Summary

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.

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.

Conditions

Pterygium

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Rotational Flap

A hinged conjunctival flap created adjacent to the excision site and rotated to cover the scleral defect while maintaining partial vascular attachment.

Group Type: EXPERIMENTAL

Conjunctival Rotational Flap

Intervention Type: PROCEDURE

A surgical technique where adjacent conjunctival tissue, remaining partially attached, is rotated to cover the exposed sclera after pterygium excision.

Conjunctival Autograft

Intervention Type: PROCEDURE

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

Conjunctival Autograft

A free conjunctival graft harvested from the superior bulbar conjunctiva and transplanted to the scleral bed after pterygium excision.

Group Type: ACTIVE_COMPARATOR

Conjunctival Rotational Flap

Intervention Type: PROCEDURE

A surgical technique where adjacent conjunctival tissue, remaining partially attached, is rotated to cover the exposed sclera after pterygium excision.

Conjunctival Autograft

Intervention Type: PROCEDURE

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

Interventions

Conjunctival Rotational Flap

A surgical technique where adjacent conjunctival tissue, remaining partially attached, is rotated to cover the exposed sclera after pterygium excision.

Intervention Type: 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

Intervention Type: PROCEDURE

Eligibility Criteria

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'

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

College of Physicians and Surgeons Pakistan

OTHER

Sponsor Role: lead

Responsible Party

Faiz ur rahman

Postgraduate Resident, Department of Operative Dentistry

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Muhammad Iqbal, MBBS

Role: CONTACT

Miqbalskt@gmail.com

+923049208484

Other Identifiers

SGTH-Oph-Pterygium-001

Identifier Type: -

Identifier Source: org_study_id