NCT03515954

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2014

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2014

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2018

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 24, 2018

Completed
10 days until next milestone

First Posted

Study publicly available on registry

May 4, 2018

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2018

Completed
Last Updated

January 2, 2019

Status Verified

December 1, 2018

Enrollment Period

3.8 years

First QC Date

April 24, 2018

Last Update Submit

December 30, 2018

Conditions

Conjunctival Neoplasms

Keywords

conjunctivasquamous neoplasiaamniotic

Outcome Measures

Primary Outcomes (1)

  • The recurrence rate of lesion

    Any recurrence which is detected clinically or/and by AS-OCT

    2 years

Interventions

Treatment of diffuse ocular surface squamous neoplasiaPROCEDURE

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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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%).

You may qualify if:

  • diffuse Ocular Surface Squamous Neoplasia

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Conjunctival Neoplasms

Condition Hierarchy (Ancestors)

Eye NeoplasmsNeoplasms by SiteNeoplasmsConjunctival DiseasesEye Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer of ophthalmology

Study Record Dates

First Submitted

April 24, 2018

First Posted

May 4, 2018

Study Start

March 1, 2014

Primary Completion

January 1, 2018

Study Completion

October 1, 2018

Last Updated

January 2, 2019

Record last verified: 2018-12