Not Yet RecruitingPhase 1

Efficacy and Safety of Topical Cyclosporine 0.05% and Lifitgrast on the Ocular Surface Symptom After Photorefractive Keratectomy in Feiz Hospital, Isfahan, 2024

Iran150 participantsStarted 2024-10-30

Plain-language summary

The goal of this clinical trial is to compare the administration of 2 drugs, cyclosporine 0.05% (Restasis) and Lifitgrast (Xiidra) before PRK, in reducing the ocular surface symptom of patients after PRK. The main questions it aims to answer are: 1- Does the use of cyclosporine 0.05% (Restasis) and Lifitgrast (Xiidra) before photorefractive keratectomy surgery (PRK) reduce ocular surface symptom such as eye pain, redness, and inflammation in conjunctivitis in patients? Researchers will compare cyclosporine 0.05% (Restasis) and Lifitgrast (Xiidra) to a placebo (Artelac artificial tears) to see if cyclosporine 0.05% and Lifitgrast works to reduce ocular surface symptom. Participants will: Take drug cyclosporine 0.05% and Lifitgrast or a Artelac 30 minutes before surgery Visit the clinic 6 hours, one day, three days and one week after photorefractive keratectomy (PRK) for checkups and tests

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: Age above 18 years Myopia and myopic astigmatism The stability of the patients refraction over the past year Not using contact lenses at least 3 weeks before the operation Absence of history of KCN and any type of corneal ectasia in the patient himself or his first degree family No history of previous eye surgery and eye trauma Absence of active eye diseases, corneal dystrophy, retinal diseases, glaucoma, dry eyes of any degree. Absence of systemic diseases that can potentially disrupt wound healing, including diabetes, vascular collagen diseases, and pregnancy. Not taking inhaled or systemic steroids actively or within 3 months before the procedure Absence of anisometropia Not using any systemic and topical analgesia during the last week Exclusion Criteria: The patients lack of consent to continue the study Failure to visit the patient for follow-up The occurrence of any complications during the patients surgery

What they're measuring

average eye inflammatory symptoms in eyes treated with cyclosporine 0.05%, Lifitgrast and Artlac 6 hours, one day, three days and one week after photorefractive keratectomy.

Timeframe: 1 week

Trial details

NCT IDNCT06624384

SponsorMohsen Pourazizi

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-11-30

Contact for this trial

Mohsen Pourazizi, Clinical Professor

0098 + 09126532785 m.pourazizi@yahoo.com