Comparing Two Surgical Methods to Prevent Pterygium Regrowth

ConditionPterygium
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorCollege of Physicians and Surgeons Pakistan

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

• Age 18-60

Either gender

Primary pterygium

Disqualifiers

• Collagen vascular disease

Autoimmune disorders

Pregnancy

Ocular surface infection

Trial design

Design model

Parallel

Treatments tested in this trial

  • Conjunctival Rotational Flap

    Procedure/Surgery

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

  • Conjunctival Autograft

    Procedure/Surgery

    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

Treatment groups

342 Participants
are divided into 2 treatment groups
Group A: Rotational FlapExperimental treatment 2 interventions
Group B: Conjunctival AutograftActive comparator 2 interventions

Trial outcomes

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.

Time frame
6 months postoperatively

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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