Condition category
Eye Diseases
Date applied
20/10/2017
Date assigned
26/10/2017
Last edited
25/10/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Corneal (the front part of the eye that covers the pupil and iris) tattooing is one of the options offered to patients with corneal opacities (problems that lead to scarring or clouding of the cornea). However, there are many other types of treatments that have impacted he popularity of corneal tattoing. Various tattooing methods have been used such as: chemical dyeing with gold or platinum chloride, and nonmetallic tattooing with Indian ink, Chinese ink, lamp black, and other organic dyes. The aim of this study is to examine if treatment of corneal opacities by painting them with Rotring Chinese ink.

Who can participate?
Patients with superficial or deep corneal opacity causing severe disfigurement or those who are blind.

What does the study involve?
The procedure is carried out in the operating room under sterile conditions by one surgeon (AHA) under topical anesthesia in all patients. Corneal epithelium is not removed. The ink is administered by multiple corneal injections with ink pre-loaded from a sterile cup. The number of injections is determined by the density of the scar and ranges from 4-8 injections. Saline solution is applied to irrigate the corneal surface to wash away excess ink and allow good visualization between injections. Contact lens are then applied and removed after one week.

What are the possible benefits and risks of participating?
Participants may benefit from an improvement in cosmetic appearance of the eyes. There are no expected risks as the maneuver was tried on rabbits before so there is no risk of dissemination or long term complication on the cornea.

Where is the study run from?
Sohag University (Egypt)

When is the study starting and how long is it expected to run for?
June 2016 to June 2017

Who is funding the study?
Sohag University Hospital (Egypt)

Who is the main contact?
Dr Engy Mostafa

Trial website

Contact information

Type

Scientific

Primary contact

Dr Engy Mostafa

ORCID ID

http://orcid.org/0000-0002-5731-1972

Contact details

Sohag University Hospital
Ophthalmology Department
Sohag
82525
Egypt

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

1

Study information

Scientific title

Outcomes of corneal tattooing by Rotring Painting Ink in disfiguring corneal opacities

Acronym

Study hypothesis

The aim of this study is to examine if treatment of corneal opacities by painting them with Rotring Chinese ink.

Ethics approval

Ethical Committee of Faculty of Medicine Sohag University, 25/07/2016

Study design

Prospective interventional non-comparative clinical study

Primary study design

Interventional

Secondary study design

Non randomised study

Trial setting

Hospitals

Trial type

Quality of life

Patient information sheet

No participant information sheet available.

Condition

Total corneal leukomas

Intervention

Participants receive conreal tatooing. The procedure is carried out in the operating room under sterile conditions by one surgeon (AHA) under topical anesthesia in all patients. Corneal epithelium is not removed. The ink is administered by multiple transepithelial intrastromal corneal injections using a 30 gauge needle attached to an insulin syringe with ink pre-loaded from a sterile cup. The bevel of the needle is up and administered tangential to the corneal surface to end up in approximately in the mid stroma avoiding accidental perforation of the cornea. The number of injections is determined by the density of the scar and ranged from 4-8 injections. Saline solution is applied to irrigate the corneal surface to wash away excess ink and allow good visualization between injections. Contact lens are then applied and removed after one week.

Postoperatively, moxiflocacin and 1% prednisolone acetate eyedrops are prescribed five times per day for two weeks. NSAID are prescribed twice daily for 3 days. Participants are followed up at one day, one week, one, three and six months. Photographs are taken after one month for comparison. Retreatment is done when needed as in inadequate coloration from the start or fading of the color.

Intervention type

Phase

Drug names

Primary outcome measures

Corneal opacity being tattooed is measured using the slitlamp to judge fading and photographing the eyes at day one, one week, and one month.

Secondary outcome measures

Postoperative complications is measured using slitlamp at day one, week one and month one and six months.

Overall trial start date

01/06/2016

Overall trial end date

30/06/2017

Reason abandoned

Eligibility

Participant inclusion criteria

1. No specific age
2. No specific gender
3. Superficial or deep corneal opacity causing severe disfigurement
4. Blind eyes

Participant type

Patient

Age group

All

Gender

Both

Target number of participants

50

Participant exclusion criteria

1. Chronically inflamed eyes
2. Severe corneal calcification or neovascularization
3. Phthisical eyes
4. Anterior

Recruitment start date

01/09/2016

Recruitment end date

30/12/2017

Locations

Countries of recruitment

Egypt

Trial participating centre

Sohag University
Sohag
82525
Egypt

Sponsor information

Organisation

Sohag Univerity Hospital

Sponsor details

Ophthalmology Department
Sohag University
Faculty of Medicine
Sohag
82525
Egypt

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Hospital/treatment centre

Funder name

Sohag University Hospital

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer reviewed journal. The protocol is available on request.

IPD sharing statement:
The datasets generated during and/or analysed during the current study are/will be available upon request from Dr Engy Mohamed Mostafa at engymostafa@yahoo.com.

Intention to publish date

30/10/2017

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes