Effect of Ectoine After Photorefractive Keratectomy (PRK).

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

15 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-01-01

Study Completion Date

2022-10-31

Brief Summary

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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.

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Detailed Description

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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 .

Conditions

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Photorefractive Keratectomy Corneal Haze

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Ectoine Eye

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

Ectohylo (R) eye drops

Intervention Type OTHER

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

Control eye

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

No interventions assigned to this group

Interventions

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Ectohylo (R) eye drops

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

Intervention Type OTHER

Other Intervention Names

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Ectoine 2% eye drops

Eligibility Criteria

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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

Minimum Eligible Age

19 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No