Rotational Narrow Strip Versus Full Conjunctival Graft in Pterygium Excision

• Sponsor: University of Malaya (Other)
• Overall Status: Completed
• CT.gov ID: NCT01083927
• Collaborator: Ministry of Health, Malaysia (Other)
• Enrollment: 94
• Location: 1
• Arms: 2
• Duration (Months): 24
• Patients Per Site Per Month: 3.9

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Pterygium	Procedure: Rotational Narrow Strip Conjunctival Graft; Procedure: Full Conjunctival Graft	N/A

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 Design

• Study Type: Interventional
• 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: Jul 1, 2007
• Actual Primary Completion Date: Jul 1, 2008
• Actual Study Completion Date: Jul 1, 2009

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Recurrence Rate of Pterygium operated with Rotational Narrow Strip Conjunctival Graft and Full Conjunctival Graft Excision [1 year]

Secondary Outcome Measures

1. Analysis of risk factors associated with recurrence of pterygium [1 year]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT01083927
• Other Study ID Numbers: UMERC003
• First Posted: Mar 10, 2010
• Last Update Posted: Mar 10, 2010
• Last Verified: Mar 1, 2010

• Keywords provided by , ,: Pterygium
• Additional relevant MeSH terms: Pterygium

Study Results

No Results Posted as of Mar 10, 2010