Effect of Ectoine After Photorefractive Keratectomy (PRK).

NCT05313425 | Unknown

• 1 other identifier: Ectoine after PRK
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Photorefractive Keratectomy; Corneal Haze

Keywords

PRK, surface ablation, corneal haze

Outcome Measures

Primary Outcomes (1)

• Corneal Densitometry (assesed by Pentacam).

  Post photo refractive keratectomy early haze (3 months after operation) assesed by Pentacam densitometry

  3 months post operative

Secondary Outcomes (2)

• Pain score (0 -10)

  2 days

• Time of Epithelial healing (days)

  2-7 days

Study Arms (2)

Ectoine Eye

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

Other: Ectohylo (R) eye drops

Control eye

The left eye of the studied group will be give Carboxymethyl cellulose, 0.2% sodium hyaluronate eye drops(Polyfresh Extra) hourly.

Interventions

Ectohylo (R) eye drops OTHER

using Ectohylo eye drops post operative after PRK in the right eyes of the patients

Also known as: Ectoine 2% eye drops

Ectoine Eye

Eligibility Criteria

• Age: 19 Years - 35 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Patient enrolled for photorefractive keratectomy for correction of myopia and myopic astigmatism.

You may qualify if:

• Patient undergoing PRK for myopia and myopic astigmatism when astigmatism is 2.5 diopters or less and myopia with spherical equivalent -4 or less.

You may not qualify if:

• 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

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Tanta University

Tanta, El Gharbia, 31512, Egypt

RECRUITING

MeSH Terms

Conditions

Corneal Opacity

Interventions

Ophthalmic Solutions; ectoine

Condition Hierarchy (Ancestors)

Corneal Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Pharmaceutical Solutions; Solutions; Pharmaceutical Preparations; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Specialty Uses of Chemicals

Study Officials

• Mohamed Elkadim

  Tanta University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mohamed Elkadim, MD

CONTACT

01004991183; mzekadem@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of ophthalmology

Study Record Dates

• First Submitted: March 29, 2022
• First Posted: April 6, 2022
• Study Start: January 1, 2022
• Primary Completion: May 1, 2022
• Study Completion: October 1, 2022
• Last Updated: April 6, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: after publication for 5 months
• Access Criteria: Authorized Ophthalmologists specialized in cornea and refractive surgery

Locations

EG (1)