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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
History of Changes

March 8, 2010
March 9, 2010
July 2007
July 2008   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01083927 on ClinicalTrials.gov Archive Site
Analysis of risk factors associated with recurrence of pterygium [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Rotational Narrow Strip Versus Full Conjunctival Graft in Pterygium Excision
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.

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.
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Pterygium
  • Procedure: Rotational Narrow Strip Conjunctival Graft
    Surgical technique
  • Procedure: Full Conjunctival Graft
    Surgical technique
  • Active Comparator: Rotational Narrow Strip Graft
    Technique of surgery
    Intervention: Procedure: Rotational Narrow Strip Conjunctival Graft
  • Active Comparator: Full Graft
    Surgical technique
    Intervention: Procedure: Full Conjunctival Graft
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
94
July 2009
July 2008   (final data collection date for primary outcome measure)

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
Both
21 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
Malaysia
 
NCT01083927
UMERC003
Yes
Dr Lo Sheau Kang, University Malaya Eye Research Center
University of Malaya
Ministry of Health, Malaysia
Principal Investigator: Lo Sheau Kang, MBBS University Malaya Eye Research Centre
University of Malaya
March 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP