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Not yet recruiting NCT07277426

Comparing Two Surgical Methods to Prevent Pterygium Regrowth

No phase Interventional Pterygium

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Conjunctival Rotational Flap, Conjunctival Autograft.
Who it may be relevant to
Registry conditions: Pterygium. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Interventions

  • 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

Primary outcome measures

  • Pterygium Recurrence Rate [Time frame: 6 months postoperatively]

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'

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07277426 · SGTH-Oph-Pterygium-001

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗