Rotational Narrow Strip Versus Full Conjunctival Graft in Pterygium Excision

NCT ID: NCT01083927

Last Updated: 2010-03-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

94 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-07-31

Study Completion Date

2009-07-31

Brief Summary

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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

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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.

Conditions

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Pterygium

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Rotational Narrow Strip Graft

Technique of surgery

Group Type ACTIVE_COMPARATOR

Rotational Narrow Strip Conjunctival Graft

Intervention Type PROCEDURE

Surgical technique

Full Graft

Surgical technique

Group Type ACTIVE_COMPARATOR

Full Conjunctival Graft

Intervention Type PROCEDURE

Surgical technique

Interventions

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Rotational Narrow Strip Conjunctival Graft

Surgical technique

Intervention Type PROCEDURE

Full Conjunctival Graft

Surgical technique

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Ministry of Health, Malaysia

OTHER_GOV

Sponsor Role collaborator

University of Malaya

OTHER

Sponsor Role lead

Responsible Party

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University Malaya Eye Research Center

Principal Investigators

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Lo Sheau Kang, MBBS

Role: PRINCIPAL_INVESTIGATOR

University Malaya Eye Research Centre

Locations

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Sarawak General Hospital

Kuching, Sarawak, Malaysia

Site Status

Countries

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Malaysia

Other Identifiers

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UMERC003

Identifier Type: -

Identifier Source: org_study_id

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