Corneal Haze, Photorefractive Keratectomy
Conditions
Keywords
PRK, surface ablation, corneal haze
Brief summary
This is a comparative, open label, parallel group, non interventional study aims to assess the effect of Ectoine containing eye drops on stromal haze, pain and epithelial healing after Photorefractive keratectomy (PRK). The patient apply Ectohylo eye drops (Ectoine +Sodium Hyauronate) in the right eye and Polyfresh Extra eye drops (Carboxymethyl cellulose + Sodium Hyauronate ) in the left eye plus the routine post PRK treatment in both eyes. Post operative pain , epithelial healing and corneal densitometry is observed in both eyes.
Detailed description
Photorefractive keratectomy (PRK) is a commonly used operation for laser vision correction. The main fears of this type of laser vision correction is corneal haze, delayed epithelial healing and postoperative severe pain. Ectoine is a natural compound that has the ability to protect biological membranes from damage and environmental effects. This study assess the use of Ectoine containing eye drops to protect the bare ocular surface and reduce inflammation after PRK that will inturn is expected to affect the post operative corneal haze, pain, and epithelial healing .
Interventions
OTHEREctohylo (R) eye drops
using Ectohylo eye drops post operative after PRK in the right eyes of the patients
Sponsors
Tanta University
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
19 Years to 35 Years
Healthy volunteers
No
Inclusion criteria
* Patient undergoing PRK for myopia and myopic astigmatism when astigmatism is 2.5 diopters or less and myopia with spherical equivalent -4 or less.
Exclusion criteria
* patient spherical equivalent more myopic than -4 diopters * Patients with astigmatism more than 2.5 diopter * Patients with anisometropia ( difference \> 2 diopters) * Patient with previous ocular surgery * Patients with chronic systemic disease that can affect results of laser vision correction (e.g. rheumatoid arthritis) * Pregnant and lactating females
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Corneal Densitometry (assesed by Pentacam). | 3 months post operative | Post photo refractive keratectomy early haze (3 months after operation) assesed by Pentacam densitometry |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain score (0 -10) | 2 days | pain in the first 2 days post operative (graded 0 to 10) |
| Time of Epithelial healing (days) | 2-7 days | Time required for epithelial healing after PRK in days |
Countries
Egypt
Contacts
Primary ContactMohamed Elkadim, MD
Outcome results
None listed