Rotational Narrow Strip Versus Full Conjunctival Graft in Pterygium Excision

Pterygium Clinical Trial

Official title:

Rotational Narrow Strip Versus Full Conjunctival Graft in Pterygium Excision

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01083927
• Other study ID #: UMERC003
• Status: Completed
• Phase: N/A
• First received: March 8, 2010
• Last updated: March 9, 2010
• Start date: July 2007
• Est. completion date: July 2009

Study information

• Verified date: March 2010
• Source: University of Malaya
• Contact: n/a
• Is FDA regulated: No
• Health authority: Malaysia: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 94
• Est. completion date: July 2009
• Est. primary completion date: July 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 21 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pterygium

Intervention

Procedure:
• Rotational Narrow Strip Conjunctival Graft
Surgical technique
• Full Conjunctival Graft
Surgical technique

Locations

Country	Name	City	State
Malaysia	Sarawak General Hospital	Kuching	Sarawak

Sponsors (2)

Lead Sponsor	Collaborator
University of Malaya	Ministry of Health, Malaysia

Country where clinical trial is conducted

Malaysia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recurrence Rate of Pterygium operated with Rotational Narrow Strip Conjunctival Graft and Full Conjunctival Graft Excision		1 year	No
Secondary	Analysis of risk factors associated with recurrence of pterygium		1 year	No