Effect of Ectoine After Photorefractive Keratectomy (PRK).

• Conditions: Photorefractive Keratectomy; Corneal Haze
• Interventions: Other: Ectohylo (R) eye drops

• Registration Number: NCT05313425
• Lead Sponsor: Tanta University

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 .

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2022-01-01
• Status Verified: 2022-03
• Study First Submitted: 2022-03-29
• Study First Submitted QC: 2022-03-29
• Last Update Submitted: 2022-03-29
• Study First Posted: 2022-04-06
• Last Update Posted: 2022-04-06
• Primary Completion: 2022-05
• Study Completion: 2022-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 15

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.

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Ectoine Eye	Ectohylo (R) eye drops	The right eye of the studied group will be given 2% Ectoine containig , 0.2% sodium hyaluronate eye drops(Ectohylo) hourly.

Primary Outcome Measures

Name	Time	Method
Corneal Densitometry (assesed by Pentacam).	3 months post operative	Post photo refractive keratectomy early haze (3 months after operation) assesed by Pentacam densitometry

Secondary Outcome Measures

Name	Time	Method
Time of Epithelial healing (days)	2-7 days	Time required for epithelial healing after PRK in days
Pain score (0 -10)	2 days	pain in the first 2 days post operative (graded 0 to 10)

Trial Locations

Locations (1)

Tanta University; 🇪🇬 Tanta, El Gharbia, Egypt