NCT01083927

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
94

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2007

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2007

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2008

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2009

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

March 8, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 10, 2010

Completed
Last Updated

March 10, 2010

Status Verified

March 1, 2010

Enrollment Period

1 year

First QC Date

March 8, 2010

Last Update Submit

March 9, 2010

Conditions

Pterygium

Keywords

Pterygium

Outcome Measures

Primary Outcomes (1)

  • Recurrence Rate of Pterygium operated with Rotational Narrow Strip Conjunctival Graft and Full Conjunctival Graft Excision

    1 year

Secondary Outcomes (1)

  • Analysis of risk factors associated with recurrence of pterygium

    1 year

Study Arms (2)

Rotational Narrow Strip Graft

ACTIVE COMPARATOR

Technique of surgery

Procedure: Rotational Narrow Strip Conjunctival Graft

Full Graft

ACTIVE COMPARATOR

Surgical technique

Procedure: Full Conjunctival Graft

Interventions

Rotational Narrow Strip Conjunctival GraftPROCEDURE

Surgical technique

Rotational Narrow Strip Graft
Full Conjunctival GraftPROCEDURE

Surgical technique

Full Graft

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Significant and symptomatic primary pterygium clinically requiring excision
  • Willingness to participate in research project and to attend research time

You may not qualify if:

  • Age \< 21 years
  • Glaucoma in the study eye
  • Other concurrent ocular surface pathology
  • Infection of the ocular surface
  • Poor general health

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sarawak General Hospital

Kuching, Sarawak, 93586, Malaysia

Location

MeSH Terms

Conditions

Pterygium

Condition Hierarchy (Ancestors)

Conjunctival DiseasesEye Diseases

Study Officials

  • Lo Sheau Kang, MBBS

    University Malaya Eye Research Centre

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 8, 2010

First Posted

March 10, 2010

Study Start

July 1, 2007

Primary Completion

July 1, 2008

Study Completion

July 1, 2009

Last Updated

March 10, 2010

Record last verified: 2010-03

Locations

MY(1)