Rotational Narrow Strip Versus Full Conjunctival Graft in Pterygium Excision
Primary Purpose
Pterygium
Status
Completed
Phase
Not Applicable
Locations
Malaysia
Study Type
Interventional
Intervention
Rotational Narrow Strip Conjunctival Graft
Full Conjunctival Graft
Sponsored by
About this trial
This is an interventional treatment trial for Pterygium focused on measuring Pterygium
Eligibility Criteria
Inclusion Criteria:
- Significant and symptomatic primary pterygium clinically requiring excision
- Willingness to participate in research project and to attend research time
Exclusion Criteria:
- Age < 21 years
- Glaucoma in the study eye
- Other concurrent ocular surface pathology
- Infection of the ocular surface
- Poor general health
Sites / Locations
- Sarawak General Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Rotational Narrow Strip Graft
Full Graft
Arm Description
Technique of surgery
Surgical technique
Outcomes
Primary Outcome Measures
Recurrence Rate of Pterygium operated with Rotational Narrow Strip Conjunctival Graft and Full Conjunctival Graft Excision
Secondary Outcome Measures
Analysis of risk factors associated with recurrence of pterygium
Full Information
NCT ID
NCT01083927
First Posted
March 8, 2010
Last Updated
March 9, 2010
Sponsor
University of Malaya
Collaborators
Ministry of Health, Malaysia
1. Study Identification
Unique Protocol Identification Number
NCT01083927
Brief Title
Rotational Narrow Strip Versus Full Conjunctival Graft in Pterygium Excision
Official Title
Rotational Narrow Strip Versus Full Conjunctival Graft in Pterygium Excision
Study Type
Interventional
2. Study Status
Record Verification Date
March 2010
Overall Recruitment Status
Completed
Study Start Date
July 2007 (undefined)
Primary Completion Date
July 2008 (Actual)
Study Completion Date
July 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University of Malaya
Collaborators
Ministry of Health, Malaysia
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pterygium
Keywords
Pterygium
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
94 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Rotational Narrow Strip Graft
Arm Type
Active Comparator
Arm Description
Technique of surgery
Arm Title
Full Graft
Arm Type
Active Comparator
Arm Description
Surgical technique
Intervention Type
Procedure
Intervention Name(s)
Rotational Narrow Strip Conjunctival Graft
Intervention Description
Surgical technique
Intervention Type
Procedure
Intervention Name(s)
Full Conjunctival Graft
Intervention Description
Surgical technique
Primary Outcome Measure Information:
Title
Recurrence Rate of Pterygium operated with Rotational Narrow Strip Conjunctival Graft and Full Conjunctival Graft Excision
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Analysis of risk factors associated with recurrence of pterygium
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Significant and symptomatic primary pterygium clinically requiring excision
Willingness to participate in research project and to attend research time
Exclusion Criteria:
Age < 21 years
Glaucoma in the study eye
Other concurrent ocular surface pathology
Infection of the ocular surface
Poor general health
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lo Sheau Kang, MBBS
Organizational Affiliation
University Malaya Eye Research Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sarawak General Hospital
City
Kuching
State/Province
Sarawak
ZIP/Postal Code
93586
Country
Malaysia
12. IPD Sharing Statement
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Rotational Narrow Strip Versus Full Conjunctival Graft in Pterygium Excision
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