The healing effect of Panthenol eye drops on eye wounds from laser vision correction surgeries
| ISRCTN | ISRCTN81441126 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN81441126 |
| Secondary identifying numbers | 005 |
- Submission date
- 10/10/2018
- Registration date
- 17/10/2018
- Last edited
- 05/04/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Eye Diseases
Plain English summary of protocol
D-Panthenol is the precursor of vitamin B5. It has a proven regenerative power on damaged body surfaces, such as burns and wounds. There are several preparations assigned for eye care containing D-Panthenol. It is added to artificial tears formula to enhance its lubricant and regenerative power.
One of the vision correction procedures is surface ablation, where the surface of the cornea is left with an epithelial defect. It is controlled and designed according to required treatment. To test its regenerative power, D-Panthenol was used on one eye and compared its effect to other similar tear drops formula, not including it, in the fellow eye.
The speed of healing will be compared in the 2 eyes of all participants.
Background and study aims
Panthenol is available and widely used in various skin ointments, creams and gels. It has proved to be a successful treatment for burns and superficial skin wounds. Panthenol eye drops are also available, which can have the same benefits as on the skin in the case of injury to the eye surface.
Surface ablation is a type of vision correction procedure that can sometimes leave the surface of the eye with a defect that heals within a few days. This study aims to look at the healing effect of panthenol drops on these surface abrasions.
Who can participate?
All patients visiting The Eye Consultants Centre in Jeddah for eye sight correction surgery
What does the study involve?
All participants will receive the surface ablation procedure as part of their usual treatment. They will then receive conventional treatment in one eye, and in the other they will additionally receive panthenol eye drops for 2 months following the surgery. Which eye receives which treatment is to be allocated at random. Participants will have examinations for the first 3 days after surgery, then weekly for 4 weeks, and then after 2 months.
What are the possible benefits and risks of participating?
The possible benefit of participating is that panthenol may increase the healing time after surgery. There are no known risks to participants taking part in this study other than the standard risks associated with laser ablation procedures.
Where is the study run from?
The Eye Consultants Centre, Jeddah (Saudi Arabia)
When is the study starting and how long is it expected to run for?
February 2016 to January 2017
Who is funding the study?
Self-funded
Who is the main contact?
Dr Islam Hamdi
islammhamdi@hotmail.com
Contact information
Scientific
The eye consultants
pobox15637
jeddah
21454
Saudi Arabia
 ORCID ID |
0000-0002-9864-3471 |
|---|---|
| Phone | +966126686161 |
| islammhamdi@hotmail.com |
Study information
| Study design | Interventional prospective randomised controlled study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | The effect of D-panthenol on corneal epithelial healing after surface laser ablation |
| Study objectives | D-Panthenol provides faster and better healing of corneal epithelial defects, than artificial tear drops alone. |
| Ethics approval(s) | The Eye Consultants Center Ethical Committee, Jeddah, Saudi Arabia, 19/04/2016 (no reference number available) |
| Health condition(s) or problem(s) studied | Epithelial corneal defects, created iatrogeniccally during surface laser ablation procedure |
| Intervention | Patients serve as their own control, with one eye randomly allocated to receive D-panthenol in propyl-methyl-cellulose eye drops four times daily for 2 months, and the other to receive carboxy methyl cellulose eye drops at the same dosage and duration. The first 23 patients will receive D-panthenol in their right eye and the next 22 patients will receive D-panthenol in their left eye. All eyes receive antibiotic eye drops (gatifloxacin) four times per day for 3 days (phase 1 of healing). During phase 2 (day 4 until the end of month 2) of healing, antibiotic eye drops will be replaced with topical corticosteroids drops (rimexolone 1%) to be used four times per day. During phase 1, patients are examined daily for 3 days. During phase 2, patients are examined weekly for 1 month, and then at at the end of month 2. For purpose of randomization, first 23 patients would receive D-panthenol in right eye and the next 22 patients would receive D-panthenol in left eye. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | D-Panthenol eye drops (Augé Vitamin TM) |
| Primary outcome measure | Rate of epithelial healing, assessed by: 1. Rate of epithelial closure, assessed on a slit lamp bio-microscope on days 1, 2 and 3 2. Corneal haze, assessed on a slit lamp bio-microscope at weeks 1, 2, 3 and 4, and the end of month 2 |
| Secondary outcome measures | 1. Effect of D-panthenol on visual acuity, assessed by: 1.1. Uncorrected visual acuity (UCVA) using a Snellen's chart at days 1, 2 and 3, weeks 1, 2, 3 and 4, and the end of month 2 1.2. Residual subjective refraction, assessed using an auto-refractometer at weeks 1, 2, 3, and 4, and the end of month 2 2. Subjective comfort with or without D-panthenol, assessed by asking participants to rate comfort out of 5, with 0 indicating "no discomfort" and 5 being "severe intolerant symptoms", at weeks 1, 2, 3 and 4, and the end of month 2 |
| Overall study start date | 14/02/2016 |
| Completion date | 31/01/2017 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 45 |
| Key inclusion criteria | 1. Ametropia 2. Seeking laser vision correction 3. Best corrected visual acuity 20/20 or better in each eye 4. Eyes fit for laser ablation procedure and otherwise normal |
| Key exclusion criteria | 1. Previous ocular surgery 2. Concomitant ocular morbidity |
| Date of first enrolment | 01/05/2016 |
| Date of final enrolment | 01/11/2016 |
Locations
Countries of recruitment
- Saudi Arabia
Study participating centre
Jeddah
21454
Saudi Arabia
Sponsor information
Hospital/treatment centre
PO Box 15637
jeddah
21454
Saudi Arabia
| Phone | +966126686161 |
|---|---|
| islammhamdi@hotmail.com | |
| Website | http://www.theeyeconsultants.net/en/ |
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | 25/10/2018 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | We intend to publish in The Journal of Ophthalmology. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request from Dr Islam Hamdi (islammhamdi@hotmail.com). All data are preserved in their personal files in The Eye Consultants Centre. Files are maintained for 3 years after the last patient visit. The master sheet and case report forms related to the study are preserved with Dr. Hamdi. Data related to the study (e.g. medical data) may be available by contacting Dr. Hamdi. Personal data not related to the nature of the study (e.g. names, addresses, etc..) will not be released, due to the privacy of the participants. The release of data for the purpose of research was agreed upon in the consent forms for participants enrolling in the study. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 12/11/2018 | 05/04/2019 | Yes | No |
Editorial Notes
05/04/2019: Publication reference added.
24/10/2018: Internal review.
