Effect of Ectoine After Photorefractive Keratectomy (PRK).

March 29, 2022 updated by: Mohamed Elkadim, Tanta University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 .

Study Type

Observational

Enrollment (Anticipated)

15

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Egypt
    • El Gharbia
      • Tanta, El Gharbia, Egypt, 31512
        • Recruiting
        • Tanta University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 35 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
using Ectohylo eye drops post operative after PRK in the right eyes of the patients
Other Names:
  • Ectoine 2% 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Corneal Densitometry (assesed by Pentacam).
Time Frame: 3 months post operative
Post photo refractive keratectomy early haze (3 months after operation) assesed by Pentacam densitometry
3 months post operative

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain score (0 -10)
Time Frame: 2 days
pain in the first 2 days post operative (graded 0 to 10)
2 days
Time of Epithelial healing (days)
Time Frame: 2-7 days
Time required for epithelial healing after PRK in days
2-7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tanta University

Investigators

  • Principal Investigator: Mohamed Elkadim, Tanta University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 1, 2022

Primary Completion (ANTICIPATED)

May 1, 2022

Study Completion (ANTICIPATED)

October 1, 2022

Study Registration Dates

First Submitted

March 29, 2022

First Submitted That Met QC Criteria

March 29, 2022

First Posted (ACTUAL)

April 6, 2022

Study Record Updates

Last Update Posted (ACTUAL)

April 6, 2022

Last Update Submitted That Met QC Criteria

March 29, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Ectoine after PRK

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Data obtained through this study may be provided to qualified researchers with academic interest in Cornea. Data or samples shared will be coded, with no PHI included. Approval of the request and execution of all applicable agreements (i.e. a material transfer agreement) are prerequisites to the sharing of data with the requesting party

IPD Sharing Time Frame

after publication for 5 months

IPD Sharing Access Criteria

Authorized Ophthalmologists specialized in cornea and refractive surgery

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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