Evaluation of Conjunctival Autografting With MMC Application Versus Ologen Implantation of Recurrent Pterygium

June 2, 2020 updated by: Amin Faisal Ellakwa, Menoufia University

Evaluation of Conjunctival Autografting Augmented With Mitomycin-C Application Versus Ologen Implantation in Surgical Treatment of Recurrent Pterygium

Ologen implantation with conjunctival autografting shows promising results in surgical management of recurrent pterygium comparable to MMC application with conjunctival autografting with mild non vision threatening postoperative complications.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Patients were randomly enrolled into two groups. Group A included 32 eyes of 32 patients who underwent conjunctival autografting augmented with topical application of Mitomycin C (0.2 mg/mL). Group B included 31 eyes of 31 who underwent conjunctival autografting augmented with Ologen implantation.

All patients had a recurrent nasal pterygium after one surgical session for removal of the primary one. Any patient with primary nasal pterygium, or patients with recurrent pterygium who had more than one session for surgical removal were excluded. As well, patients with cicatrizing conjunctival disease or previous conjunctival surgery were excluded from the study.

A comprehensive ophthalmic examination, including best-corrected visual acuity testing, slit-lamp examination, Goldmann applanation tonometry, fundus examination, and examination of ocular motility, was carried out for all patients. According to their corneal extent, pterygia were classified into 3 grades:

Grade 1: Fibrovascular proliferations extend up to one quarter of the corneal diameter.

Grade 2: Fibrovascular proliferations extend up to the center of the cornea. Grade 3: Fibrovascular proliferations extend beyond the visual axis.

Consents were taken from all patients and research was approved by the institutional review board. All measures were in accordance with the tenets of the Declaration of Helsinki.

As for group A, 0.2 mg/mL MMC was prepared by reconstituting 2 mg vial of Mitomycin with 10 mL sterile water for injection. When using Mitomycin 10 mg vial, the same concentration was achieved by reconstituting the 10 mg vial 10 mL sterile water for injection. Then 1 ml of the prepared solution was diluted with 4 ml of saline to achieve 0.2 mg/mL (0.02% solution). This solution is stable for 2 weeks under refrigeration, and 24 hours at room temperature (59° to 86°F).

As for group B, 1×2 or 2×2 square millimeter porous collagen matrix was used for each patient

Study Type

Interventional

Enrollment (Actual)

63

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

recurrent nasal pterygium after one surgical session for removal of the primary one

Exclusion Criteria:

  • primary nasal pterygium,
  • recurrent pterygium with more than one session for surgical removal

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: conjunctival autografting with MMC
Group A included 32 eyes of 32 patients who underwent conjunctival autografting augmented with topical application of Mitomycin C (0.2 mg/mL).
Procedure: conjunctival autografting augmented with topical application of Mitomycin C
Group A included 32 eyes of 32 patients who underwent conjunctival autografting augmented with topical application of Mitomycin C (0.2 mg/mL).
Procedure: conjunctival autografting augmented with Ologen implantation
Group B included 31 eyes of 31 who underwent conjunctival autografting augmented with Ologen implantation.
ACTIVE_COMPARATOR: conjunctival autografting augmented with Ologen implantation
Group B included 31 eyes of 31 who underwent conjunctival autografting augmented with Ologen implantation.
Procedure: conjunctival autografting augmented with topical application of Mitomycin C
Group A included 32 eyes of 32 patients who underwent conjunctival autografting augmented with topical application of Mitomycin C (0.2 mg/mL).
Procedure: conjunctival autografting augmented with Ologen implantation
Group B included 31 eyes of 31 who underwent conjunctival autografting augmented with Ologen implantation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
32 eyes with Topical application of Mitomycin C in concentration of (0.2 mg/mL).
Time Frame: "through study completion, an average of 1 year".
As for group A, 0.2 mg/mL MMC was prepared by reconstituting 2 mg vial of Mitomycin with 10 mL sterile water for injection. When using Mitomycin 10 mg vial, the same concentration was achieved by reconstituting the 10 mg vial 10 mL sterile water for injection. Then 1 ml of the prepared solution was diluted with 4 ml of saline to achieve 0.2 mg/mL (0.02% solution).
"through study completion, an average of 1 year".
31 eyes with ologen implantation(6 mm in diameter and 2 mm thick.) was used for each patient.
Time Frame: "through study completion, an average of 1 year".
In group B; Ologen was applied under the graft tissue once it is secured in place (half the vial is used for every patient)
"through study completion, an average of 1 year".

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Menoufia University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 15, 2016

Primary Completion (ACTUAL)

December 1, 2019

Study Completion (ACTUAL)

December 30, 2019

Study Registration Dates

First Submitted

May 14, 2020

First Submitted That Met QC Criteria

June 2, 2020

First Posted (ACTUAL)

June 5, 2020

Study Record Updates

Last Update Posted (ACTUAL)

June 5, 2020

Last Update Submitted That Met QC Criteria

June 2, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 81046

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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