Corneal tattooing for corneal opacities
| ISRCTN | ISRCTN46626979 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN46626979 |
| Secondary identifying numbers | 1 |
- Submission date
- 20/10/2017
- Registration date
- 26/10/2017
- Last edited
- 25/11/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Eye Diseases
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
Contact information
Scientific
Sohag University Hospital
Ophthalmology Department
Sohag
82525
Egypt
 ORCID ID |
0000-0002-5731-1972 |
|---|
Study information
| Study design | Prospective interventional non-comparative clinical study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Hospital |
| Study type | Quality of life |
| Participant information sheet | No participant information sheet available. |
| Scientific title | Outcomes of corneal tattooing by Rotring Painting Ink in disfiguring corneal opacities |
| Study hypothesis | The aim of this study is to examine if treatment of corneal opacities by painting them with Rotring Chinese ink. |
| Ethics approval(s) | Ethical Committee of Faculty of Medicine Sohag University, 25/07/2016 |
| 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 | Procedure/Surgery |
| Primary outcome measure | 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 study start date | 01/06/2016 |
| Overall study end date | 30/06/2017 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | All |
| Sex | Both |
| Target number of participants | 50 |
| Total final enrolment | 53 |
| Participant inclusion criteria | 1. No specific age 2. No specific gender 3. Superficial or deep corneal opacity causing severe disfigurement 4. Blind eyes |
| 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
Study participating centre
82525
Egypt
Sponsor information
Hospital/treatment centre
Ophthalmology Department
Sohag University
Faculty of Medicine
Sohag
82525
Egypt
"ROR" |
https://ror.org/02wgx3e98 |
|---|
Funders
Funder type
Hospital/treatment centre
No information available
Results and Publications
| Intention to publish date | 30/10/2017 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high-impact peer reviewed journal. The protocol is available on request. |
| IPD sharing plan | 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. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 25/06/2018 | 25/11/2020 | Yes | No |
Editorial Notes
25/11/2020: Publication reference and total final enrolment number added.
