AS-OCT Guided Treatment of Diffuse CSCC

December 30, 2018 updated by: Tarek Roshdy mohamed Mahgoub ELhamaky, Benha University

Anterior Segment Optical Coherence Tomography (AS-OCT) Guided Treatment of Diffuse Conjunctival Squamous Cell Carcinoma (CSCC) With Excision, Amniotic Membrane Graft Using Fibrin Glue and Topical Mitomycin C (MMC)

A prospective study was performed on 8 eyes of 8 patients who underwent amniotic membrane graft after diffuse conjunctival squamous cell neoplasia excision followed by topical mitomycin C 0.04% eye drop between March 2014 and January 2018.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Surgical excision of the conjunctival tumour . A superficial corneal scraping was performed for corneal lesion then double freeze-thaw cryotherapy was applied to limbal edge and conjunctival margins.The amniotic membrane graft was secure and attached to the sclera and conjunctiva using fibrin glue.Topical mitomycin C 0.04%eye drop was prescribed 4 times daily per treatment cycle (1 cycle=1 week on 1 week off).

Study Type

Observational

Enrollment (Actual)

15

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

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

This study included 8 eyes of 8 patients. The mean age of all patients was 51.9 ± 9.9 years. There were 7 males (87.5%) and 1 female (12.5%).

Description

Inclusion Criteria:

  • diffuse Ocular Surface Squamous Neoplasia

Exclusion Criteria:

  • localized OSSN (less than five clock hours in limbal extent)

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The recurrence rate of lesion
Time Frame: 2 years
Any recurrence which is detected clinically or/and by AS-OCT
2 years

Collaborators and Investigators

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

Sponsor

Benha University

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)

March 1, 2014

Primary Completion (ACTUAL)

January 1, 2018

Study Completion (ACTUAL)

October 1, 2018

Study Registration Dates

First Submitted

April 24, 2018

First Submitted That Met QC Criteria

April 24, 2018

First Posted (ACTUAL)

May 4, 2018

Study Record Updates

Last Update Posted (ACTUAL)

January 2, 2019

Last Update Submitted That Met QC Criteria

December 30, 2018

Last Verified

December 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • benha19992

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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