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AS-OCT Guided Treatment of Diffuse CSCC

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03515954
Recruitment Status : Completed
First Posted : May 4, 2018
Last Update Posted : January 2, 2019
Information provided by (Responsible Party):
Tarek Roshdy mohamed Mahgoub ELhamaky, Benha University

Brief Summary:
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.

Condition or disease Intervention/treatment
Conjunctival Neoplasms Procedure: Treatment of diffuse ocular surface squamous neoplasia

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).

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Study Type : Observational
Actual Enrollment : 15 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: 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)
Actual Study Start Date : March 2014
Actual Primary Completion Date : January 2018
Actual Study Completion Date : October 2018

Intervention Details:
  • Procedure: Treatment of diffuse ocular surface squamous neoplasia
    Excision of the conjunctival tumour was done.Amniotic membrane was secured into conjunctival defects. Postoperative topical MMC 0.04% was given. Response to treatment was monitored clinically and by AS-OCT.

Primary Outcome Measures :
  1. The recurrence rate of lesion [ Time Frame: 2 years ]
    Any recurrence which is detected clinically or/and by AS-OCT

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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%).

Inclusion Criteria:

  • diffuse Ocular Surface Squamous Neoplasia

Exclusion Criteria:

  • localized OSSN (less than five clock hours in limbal extent)
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Responsible Party: Tarek Roshdy mohamed Mahgoub ELhamaky, lecturer of ophthalmology, Benha University Identifier: NCT03515954    
Other Study ID Numbers: benha19992
First Posted: May 4, 2018    Key Record Dates
Last Update Posted: January 2, 2019
Last Verified: December 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Tarek Roshdy mohamed Mahgoub ELhamaky, Benha University:
squamous neoplasia
Additional relevant MeSH terms:
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Conjunctival Neoplasms
Eye Neoplasms
Neoplasms by Site
Conjunctival Diseases
Eye Diseases