Comparing Two Surgical Methods to Prevent Pterygium Regrowth

NCT07277426 | Not Yet Recruiting

• 1 other identifier: SGTH-Oph-Pterygium-001
• Study Type: interventional
• Target: 342
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Pterygium

Keywords

Conjunctival Autograft; Conjunctival Rotational Flap; Pterygium Recurrence

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Rotational Flap

EXPERIMENTAL

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; Procedure: Conjunctival Autograft

Conjunctival Autograft

ACTIVE COMPARATOR

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

Procedure: Conjunctival Rotational Flap; Procedure: Conjunctival Autograft

Interventions

Conjunctival Rotational Flap PROCEDURE

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

Conjunctival Autograft; Rotational Flap

Conjunctival Autograft 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; Rotational Flap

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-60
• Either gender
• Primary pterygium

You may not qualify if:

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

Sponsors & Collaborators

• College of Physicians and Surgeons Pakistan: lead

MeSH Terms

Conditions

Pterygium

Condition Hierarchy (Ancestors)

Conjunctival Diseases; Eye Diseases

Central Study Contacts

Muhammad Iqbal, MBBS

CONTACT

+923049208484; Miqbalskt@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Postgraduate Resident, Department of Operative Dentistry

Model Details: Participants are randomly assigned to one of two parallel groups for the duration of the study

Study Record Dates

• First Submitted: November 30, 2025
• First Posted: December 11, 2025
• Study Start: February 2, 2026
• Primary Completion (Estimated): July 2, 2026
• Study Completion (Estimated): July 2, 2026
• Last Updated: December 11, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share