NCT02009072

Brief Summary

Pterygium is a common ocular pathology facing ophthalmologists that has varied surgical management techniques and high rate of post-operative recurrence. The investigators aim was to compare and evaluate the safety and efficacy outcomes of those two surgical procedures in management of primary pterygium.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2010

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2010

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2010

Completed
2.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2012

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

December 2, 2013

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 11, 2013

Completed
Last Updated

January 7, 2014

Status Verified

January 1, 2014

Enrollment Period

6 months

First QC Date

December 2, 2013

Last Update Submit

January 5, 2014

Conditions

Pterygium

Keywords

Pterygium surgerySutureless glue free conjunctival autograftAmniotic membrane graft.

Outcome Measures

Primary Outcomes (1)

  • Recurrence Rate

    The main postoperative primary outcomes measure the recurrence rate which was defined as fibrovascular proliferation invading the cornea more than 1.5 mm at the site of previously excised pterygium.

    24 months

Secondary Outcomes (3)

  • Postoperative signs and symptoms

    Third postoperative day,then weekly for one month

  • Overall patient satisfaction

    Third post-operative week

  • Complications

    24 months

Other Outcomes (2)

  • Operative time

    Intraoperative

  • Gain in uncorrected visual acuity (UCVA)

    First post-operative month

Study Arms (2)

Sutured limbal conjunctival autograft

EXPERIMENTAL

Sutured limbal conjunctival autograft was done for patients of group 2 after pterygium excision

Procedure: Sutured limbal conjunctival autograft

Suturless and glue free Limbal conjuctival autograft

EXPERIMENTAL

Sutureless and glue free Limbal conjunctival autograft was done for patients of group 1 after pterygium excision

Procedure: Sutureless and glue free limbal conjunctival autograft

Interventions

Sutureless and glue free limbal conjunctival autograftPROCEDURE

Simple pterygium excision under local anesthesia was performed then closure of the bare sclera by sutureless and glue free conjunctival autograft in 50 eyes of 50 patients (group 1)

Also known as: Sutureless and glue free LCAG
Suturless and glue free Limbal conjuctival autograft
Sutured limbal conjunctival autograftPROCEDURE

Simple pterygium excision under local anesthesia was performed then closure of the bare sclera by sutured limbal conjunctival autograft in 100 eyes of 100 patients (group 2).

Also known as: Sutured LCAG
Sutured limbal conjunctival autograft

Eligibility Criteria

Age24 Years - 74 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients complaining of primary pterygium with eye redness. Patients with pterygium threatening the visual axis.

You may not qualify if:

  • All cases not completed the follow up period for two years. Atrophic pterygium, pseudopterygium or double head pterygium.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shaaban A Elwan

Al Minyā, Egypt

Location

MeSH Terms

Conditions

Pterygium

Condition Hierarchy (Ancestors)

Conjunctival DiseasesEye Diseases

Study Officials

  • Shaaban A Elwan, Assist Prof Ophth

    Ophthalmology Dep., Al-Minya University Hospitals, Al-Minya, Egypt

    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
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assisstent professor of ophthalmology

Study Record Dates

First Submitted

December 2, 2013

First Posted

December 11, 2013

Study Start

April 1, 2010

Primary Completion

October 1, 2010

Study Completion

November 1, 2012

Last Updated

January 7, 2014

Record last verified: 2014-01

Locations

EG(1)