Comparing Two Surgical Methods to Prevent Pterygium Regrowth

College of Physicians and Surgeons Pakistan

Status: Not yet enrolling

Conditions: Pterygium

Treatments: Procedure: Conjunctival Rotational Flap; Procedure: Conjunctival Autograft

Study type: Interventional

Funder types: Other

Identifiers

NCT07277426

SGTH-Oph-Pterygium-001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 342 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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'

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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342 participants in 2 patient groups

Rotational Flap

Experimental group

Description:

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

Treatment:

Procedure: Conjunctival Autograft

Procedure: Conjunctival Rotational Flap

Conjunctival Autograft

Active Comparator group

Description:

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

Treatment:

Procedure: Conjunctival Autograft

Procedure: Conjunctival Rotational Flap