search
Back to results

Comparison Between Sutureless and Glue Free Versus Sutured Limbal Conjunctival Autograft in Primary Pterygium Surgery

Primary Purpose

Pterygium

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Sutureless and glue free limbal conjunctival autograft
Sutured limbal conjunctival autograft
Sponsored by
Shaaban Elwan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pterygium focused on measuring Pterygium surgery, Sutureless glue free conjunctival autograft, Amniotic membrane graft.

Eligibility Criteria

24 Years - 74 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

  • Shaaban A Elwan

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Sutured limbal conjunctival autograft

Suturless and glue free Limbal conjuctival autograft

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Postoperative signs and symptoms
The secondary outcomes measure, postoperative pain, foreign body sensation, photophobia, hyperemia and chemosis.
Overall patient satisfaction
Overall satisfaction with the procedure 3 weeks post-operatively was recorded as four grades 0= unsatisfied, 1= low satisfaction, 2= moderate satisfaction and 3= highly satisfied, the data were collected as mean scores and recorded. The two groups were compared for overall satisfaction.
Complications
Complications was recorded including, persistent epithelial defect, dellen, inclusion cyst, pyogenic granuloma, conjunctival edema, corneal scleral necrosis, infective scleritis, keratitis and endophthalmitis.

Full Information

First Posted
December 2, 2013
Last Updated
January 5, 2014
Sponsor
Shaaban Elwan
Collaborators
Minia University
search

1. Study Identification

Unique Protocol Identification Number
NCT02009072
Brief Title
Comparison Between Sutureless and Glue Free Versus Sutured Limbal Conjunctival Autograft in Primary Pterygium Surgery
Official Title
Comparison Between Sutureless and Glue Free Versus Sutured Limbal Conjunctival Autograft in Primary Pterygium Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
January 2014
Overall Recruitment Status
Completed
Study Start Date
April 2010 (undefined)
Primary Completion Date
October 2010 (Actual)
Study Completion Date
November 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Shaaban Elwan
Collaborators
Minia University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
Design: Prospective randomized clinical trial comparative study. Setting: Department of ophthalmology, Al-Minia University Faculty of medicine, Egypt. Methods: The study included 150 eyes of 150 patients of primary pterygium. Twenty four to 74 years of age (mean 49 ± 12 years). Simple 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), versus sutured free conjunctival autograft in 100 eyes of 100 patients (group 2).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pterygium
Keywords
Pterygium surgery, Sutureless glue free conjunctival autograft, Amniotic membrane graft.

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
150 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sutured limbal conjunctival autograft
Arm Type
Experimental
Arm Description
Sutured limbal conjunctival autograft was done for patients of group 2 after pterygium excision
Arm Title
Suturless and glue free Limbal conjuctival autograft
Arm Type
Experimental
Arm Description
Sutureless and glue free Limbal conjunctival autograft was done for patients of group 1 after pterygium excision
Intervention Type
Procedure
Intervention Name(s)
Sutureless and glue free limbal conjunctival autograft
Other Intervention Name(s)
Sutureless and glue free LCAG
Intervention Description
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)
Intervention Type
Procedure
Intervention Name(s)
Sutured limbal conjunctival autograft
Other Intervention Name(s)
Sutured LCAG
Intervention Description
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).
Primary Outcome Measure Information:
Title
Recurrence Rate
Description
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.
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Postoperative signs and symptoms
Description
The secondary outcomes measure, postoperative pain, foreign body sensation, photophobia, hyperemia and chemosis.
Time Frame
Third postoperative day,then weekly for one month
Title
Overall patient satisfaction
Description
Overall satisfaction with the procedure 3 weeks post-operatively was recorded as four grades 0= unsatisfied, 1= low satisfaction, 2= moderate satisfaction and 3= highly satisfied, the data were collected as mean scores and recorded. The two groups were compared for overall satisfaction.
Time Frame
Third post-operative week
Title
Complications
Description
Complications was recorded including, persistent epithelial defect, dellen, inclusion cyst, pyogenic granuloma, conjunctival edema, corneal scleral necrosis, infective scleritis, keratitis and endophthalmitis.
Time Frame
24 months
Other Pre-specified Outcome Measures:
Title
Operative time
Description
Calculation of operative time for each patient procedure
Time Frame
Intraoperative
Title
Gain in uncorrected visual acuity (UCVA)
Description
Gain in uncorrected visual acuity (UCVA) for each patient from the base line measurement
Time Frame
First post-operative month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
24 Years
Maximum Age & Unit of Time
74 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients complaining of primary pterygium with eye redness. Patients with pterygium threatening the visual axis. Exclusion Criteria: All cases not completed the follow up period for two years. Atrophic pterygium, pseudopterygium or double head pterygium.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shaaban A Elwan, Assist Prof Ophth
Organizational Affiliation
Ophthalmology Dep., Al-Minya University Hospitals, Al-Minya, Egypt
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shaaban A Elwan
City
Al Minya
Country
Egypt

12. IPD Sharing Statement

Learn more about this trial

Comparison Between Sutureless and Glue Free Versus Sutured Limbal Conjunctival Autograft in Primary Pterygium Surgery

We'll reach out to this number within 24 hrs