Condition category
Eye Diseases
Date applied
10/10/2018
Date assigned
17/10/2018
Last edited
24/10/2018
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

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

Trial website

Contact information

Type

Scientific

Primary contact

Dr Islam Hamdi

ORCID ID

http://orcid.org/0000-0002-9864-3471

Contact details

The eye consultants
pobox15637
jeddah
21454
Saudi Arabia
+966126686161
islammhamdi@hotmail.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

005

Study information

Scientific title

The effect of D-panthenol on corneal epithelial healing after surface laser ablation

Acronym

Study hypothesis

D-Panthenol provides faster and better healing of corneal epithelial defects, than artificial tear drops alone.

Ethics approval

The Eye Consultants Center Ethical Committee, Jeddah, Saudi Arabia, 19/04/2016 (no reference number available)

Study design

Interventional prospective randomised controlled study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

Condition

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

Phase

Not Applicable

Drug names

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 trial start date

14/02/2016

Overall trial end date

31/01/2017

Reason abandoned (if study stopped)

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

45

Participant exclusion criteria

1. Previous ocular surgery
2. Concomitant ocular morbidity

Recruitment start date

01/05/2016

Recruitment end date

01/11/2016

Locations

Countries of recruitment

Saudi Arabia

Trial participating centre

The Eye Consultants Center
PO Box 15637
Jeddah
21454
Saudi Arabia

Sponsor information

Organisation

The Eye Consultants Center

Sponsor details

PO Box 15637
jeddah
21454
Saudi Arabia
+966126686161
islammhamdi@hotmail.com

Sponsor type

Hospital/treatment centre

Website

http://www.theeyeconsultants.net/en/

Funders

Funder type

Other

Funder name

Investigator initiated and funded

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

We intend to publish in The Journal of Ophthalmology.

IPD sharing statement:
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.

Intention to publish date

25/10/2018

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

24/10/2018: Internal review.