AS-OCT Guided Treatment of Diffuse CSCC

Conjunctival Neoplasms Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03515954
• Other study ID #: benha19992
• Status: Completed
• Start date: March 2014
• Est. completion date: October 2018

Study information

• Verified date: December 2018
• Source: Benha University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: October 2018
• Est. primary completion date: January 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• diffuse Ocular Surface Squamous Neoplasia

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Conjunctival Neoplasms

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Benha University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The recurrence rate of lesion	Any recurrence which is detected clinically or/and by AS-OCT	2 years