An observational study in Photorefractive Keratectomy and Corneal Haze, sponsored by Tanta University. Status unknown at 1 site in Egypt. Open to participants aged 19 Years to 35 Years. Per ClinicalTrials.gov, last updated 2022-04-06.
Sponsored by Tanta University · Observational
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.
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 .
37 studies on the registry are indexed under Corneal Opacity; 5 are open to participants now.
This study's planned enrollment of 15 is below the median of 45 across 14 observational studies indexed under Corneal Opacity.
Browse Corneal Opacity studies →Tanta University is the lead sponsor of 1,010 studies on the registry; 321 are open to participants now.
Of its 15 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Patient enrolled for photorefractive keratectomy for correction of myopia and myopic astigmatism.
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Exclusion Criteria:
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
The left eye of the studied group will be give Carboxymethyl cellulose, 0.2% sodium hyaluronate eye drops(Polyfresh Extra) hourly.
using Ectohylo eye drops post operative after PRK in the right eyes of the patients
Also known as: Ectoine 2% eye drops
Corneal Densitometry (assesed by Pentacam).
Post photo refractive keratectomy early haze (3 months after operation) assesed by Pentacam densitometry
Time frame: 3 months post operative
Pain score (0 -10)
pain in the first 2 days post operative (graded 0 to 10)
Time frame: 2 days
Time of Epithelial healing (days)
Time required for epithelial healing after PRK in days
Time frame: 2-7 days
Plan to share: Yes — 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
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report
Time frame: after publication for 5 months
Access criteria: Authorized Ophthalmologists specialized in cornea and refractive surgery
No publications or documents are linked to this record.
This study is status unknown, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.
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