Effect of Ectoine After Photorefractive Keratectomy (PRK).

Photorefractive Keratectomy Clinical Trial

Official title:

Effect of Ectoine on Stromal Haze, Wound Healing and Pain After Photorefractive Keratectomy.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05313425
• Other study ID #: Ectoine after PRK
• Status: Recruiting
• Start date: January 1, 2022
• Est. completion date: October 2022

Study information

• Verified date: March 2022
• Source: Tanta University
• Contact: Mohamed Elkadim, MD
• Phone: 01004991183
• Email: mzekadem[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 .

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: October 2022
• Est. primary completion date: May 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Corneal Opacity
• Photorefractive Keratectomy

Intervention

Other:
• Ectohylo (R) eye drops
using Ectohylo eye drops post operative after PRK in the right eyes of the patients

Locations

Country	Name	City	State
Egypt	Tanta University	Tanta	El Gharbia

Sponsors (1)

Lead Sponsor	Collaborator
Tanta University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Corneal Densitometry (assesed by Pentacam).	Post photo refractive keratectomy early haze (3 months after operation) assesed by Pentacam densitometry	3 months post operative
Secondary	Pain score (0 -10)	pain in the first 2 days post operative (graded 0 to 10)	2 days
Secondary	Time of Epithelial healing (days)	Time required for epithelial healing after PRK in days	2-7 days