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Rotational Narrow Strip Versus Full Conjunctival Graft in Pterygium Excision

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ClinicalTrials.gov Identifier: NCT01083927
Recruitment Status : Completed
First Posted : March 10, 2010
Last Update Posted : March 10, 2010
Sponsor:
Collaborator:
Ministry of Health, Malaysia
Information provided by:
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.

Condition or disease Intervention/treatment
Pterygium 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  (Clinical Trial)
Actual Enrollment : 94 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Rotational Narrow Strip Versus Full Conjunctival Graft in Pterygium Excision
Study Start Date : July 2007
Primary Completion Date : July 2008
Study Completion Date : July 2009

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



Primary Outcome Measures :
  1. Recurrence Rate of Pterygium operated with Rotational Narrow Strip Conjunctival Graft and Full Conjunctival Graft Excision [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Analysis of risk factors associated with recurrence of pterygium [ Time Frame: 1 year ]


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Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Dr Lo Sheau Kang, University Malaya Eye Research Center
ClinicalTrials.gov Identifier: NCT01083927     History of Changes
Other Study ID Numbers: UMERC003
First Posted: March 10, 2010    Key Record Dates
Last Update Posted: March 10, 2010
Last Verified: March 2010

Keywords provided by University of Malaya:
Pterygium

Additional relevant MeSH terms:
Pterygium
Conjunctival Diseases
Eye Diseases