Rotational Narrow Strip Versus Full Conjunctival Graft in Pterygium Excision

Not Applicable

Completed

• Conditions: Pterygium
• Interventions: Procedure: Rotational Narrow Strip Conjunctival Graft; Procedure: Full Conjunctival Graft

• Registration Number: NCT01083927
• Lead Sponsor: University of Malaya

Brief Summary

To compare the efficacy of rotational narrow strip conjunctival graft to full conjunctival graft in primary pterygium excision. Risk analysis of factors that may affects the recurrence rate.

Detailed Description

Pterygium is a raised, wing-shaped growth of fibrovascular tissue that extends horizontally from the bulbar conjunctiva, crossing the limbus, and onto the cornea. It is a common ocular surface disease in Malaysia.

Pterygium can cause chronic ocular irritation, redness, tearing, visual impairment and poor cosmesis. Treatment of symptomatic pterygium remains surgical. Surgery should achieve low recurrence rate and acceptable cosmesis. Various surgical techniques had been described with variable success.

In this study, we compared the efficacy of Rotational Narrow Strip Conjunctival Graft with the conventional full conjunctival graft in pterygium excision. Patient will be follow up for a year after pterygium surgery. Outcome will be recurrence rate between the two groups at one year. Risk analysis of certain factors that affects the recurrence rate will be discussed.

Study Timeline

• Study Start: 2007-07
• Primary Completion: 2008-07
• Study Completion: 2009-07
• Status Verified: 2010-03
• Study First Submitted: 2010-03-08
• Study First Submitted QC: 2010-03-09
• Last Update Submitted: 2010-03-09
• Study First Posted: 2010-03-10
• Last Update Posted: 2010-03-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 94

Inclusion Criteria

1. Significant and symptomatic primary pterygium clinically requiring excision
2. Willingness to participate in research project and to attend research time

Exclusion Criteria

1. Age < 21 years
2. Glaucoma in the study eye
3. Other concurrent ocular surface pathology
4. Infection of the ocular surface
5. Poor general health

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Rotational Narrow Strip Graft	Rotational Narrow Strip Conjunctival Graft	Technique of surgery
Full Graft	Full Conjunctival Graft	Surgical technique

Primary Outcome Measures

Name	Time	Method
Recurrence Rate of Pterygium operated with Rotational Narrow Strip Conjunctival Graft and Full Conjunctival Graft Excision	1 year

Secondary Outcome Measures

Name	Time	Method
Analysis of risk factors associated with recurrence of pterygium	1 year

Trial Locations

Locations (1)

Sarawak General Hospital; 🇲🇾 Kuching, Sarawak, Malaysia