Effect of Ectoine After Photorefractive Keratectomy (PRK).

T

Tanta University

Status

Enrolling

Conditions

Corneal Haze
Photorefractive Keratectomy

Treatments

Other: Ectohylo (R) eye drops

Study type

Observational

Funder types

Other

Identifiers

NCT05313425
Ectoine after PRK

Details and patient eligibility

About

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.

Full 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 .

Enrollment

15 estimated patients

Sex

All

Ages

19 to 35 years old

Volunteers

No Healthy Volunteers

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

Trial design

15 participants in 2 patient groups

Ectoine Eye
Description:
The right eye of the studied group will be given 2% Ectoine containig , 0.2% sodium hyaluronate eye drops(Ectohylo) hourly.
Treatment:
Other: Ectohylo (R) eye drops
Control eye
Description:
The left eye of the studied group will be give Carboxymethyl cellulose, 0.2% sodium hyaluronate eye drops(Polyfresh Extra) hourly.

Trial contacts and locations

1

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Central trial contact

Mohamed Elkadim, MD

Data sourced from clinicaltrials.gov

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