Rotational Narrow Strip Versus Full Conjunctival Graft in Pterygium Excision

This study has been completed.
Sponsor:
Collaborator:
Ministry of Health, Malaysia
Information provided by:
University of Malaya
ClinicalTrials.gov Identifier:
NCT01083927
First received: March 8, 2010
Last updated: March 9, 2010
Last verified: March 2010
  Purpose

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.


Condition Intervention
Pterygium
Procedure: Rotational Narrow Strip Conjunctival Graft
Procedure: Full Conjunctival Graft

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Rotational Narrow Strip Versus Full Conjunctival Graft in Pterygium Excision

Further study details as provided by University of Malaya:

Primary Outcome Measures:
  • Recurrence Rate of Pterygium operated with Rotational Narrow Strip Conjunctival Graft and Full Conjunctival Graft Excision [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Analysis of risk factors associated with recurrence of pterygium [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Enrollment: 94
Study Start Date: July 2007
Study Completion Date: July 2009
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01083927

Locations
Malaysia
Sarawak General Hospital
Kuching, Sarawak, Malaysia, 93586
Sponsors and Collaborators
University of Malaya
Ministry of Health, Malaysia
Investigators
Principal Investigator: Lo Sheau Kang, MBBS University Malaya Eye Research Centre
  More Information

No publications provided

Responsible Party: Dr Lo Sheau Kang, University Malaya Eye Research Center
ClinicalTrials.gov Identifier: NCT01083927     History of Changes
Other Study ID Numbers: UMERC003
Study First Received: March 8, 2010
Last Updated: March 9, 2010
Health Authority: Malaysia: Ministry of Health

Keywords provided by University of Malaya:
Pterygium

Additional relevant MeSH terms:
Pterygium
Conjunctival Diseases
Eye Diseases

ClinicalTrials.gov processed this record on October 21, 2014