Rotational Narrow Strip Versus Full Conjunctival Graft in Pterygium Excision

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.

Study Overview

• Status: Completed
• Conditions: Pterygium
• Intervention / Treatment: Procedure: Rotational Narrow Strip Conjunctival Graft; Procedure: Full Conjunctival Graft

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 Type: Interventional
• Enrollment (Actual): 94
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Malaysia
  • Sarawak
    • Kuching, Sarawak, Malaysia, 93586
      • Sarawak General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Rotational Narrow Strip Graft; Technique of surgery	Procedure: Rotational Narrow Strip Conjunctival Graft; Surgical technique
Active Comparator: Full Graft; Surgical technique	Procedure: Full Conjunctival Graft; Surgical technique

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Recurrence Rate of Pterygium operated with Rotational Narrow Strip Conjunctival Graft and Full Conjunctival Graft Excision	1 year

Secondary Outcome Measures

Outcome Measure	Time Frame
Analysis of risk factors associated with recurrence of pterygium	1 year

Collaborators and Investigators

• Sponsor: University of Malaya
• Collaborators: Ministry of Health, Malaysia
• Investigators: Principal Investigator: Lo Sheau Kang, MBBS, University Malaya Eye Research Centre

Study record dates

Study Major Dates

• Study Start: July 1, 2007
• Primary Completion (Actual): July 1, 2008
• Study Completion (Actual): July 1, 2009

Study Registration Dates

• First Submitted: March 8, 2010
• First Submitted That Met QC Criteria: March 9, 2010
• First Posted (Estimate): March 10, 2010

Study Record Updates

• Last Update Posted (Estimate): March 10, 2010
• Last Update Submitted That Met QC Criteria: March 9, 2010
• Last Verified: March 1, 2010

More Information

Terms related to this study

• Keywords: Pterygium
• Additional Relevant MeSH Terms: Eye Diseases; Conjunctival Diseases; Pterygium
• Other Study ID Numbers: UMERC003