Evaluation of the efficacy of in-situ gelling ocular formulation containing ketorolac to reduce patients' pain and comfort after Photorefractive keratectomy

Evaluation of the efficacy of in-situ gelling ocular formulation containing ketorolac in hydroxypropyl methyl cellulose - poloxamer mucoadhesive base in comparison with ketorolac eye drops to reduce patients' pain and comfort after Photorefractive keratectomy

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20221113056492N1

Enrollment

Registered

2023-05-04

Start date

2023-05-05

Completion date

Unknown

Last updated

2023-05-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Reduction of patients' pain and comfort after Photorefractive keratectomy. Diseases of the eye and adnexa

Interventions

Intervention 1: Intervention group: In-situ gelling ocular drop containing ketorolac. Patients receive this drug in the form of 1 drop 3 times a day for 3 days after placing the bandage contact lens.

Eligibility

Sex/Gender

All

Age

18 Years to 60 Years

Inclusion criteria

Inclusion criteria: Patients with indication of refractive surgery of both eyes Age between 18 to 60 years Satisfaction of patients

Exclusion criteria

Exclusion criteria: Refractive surgery in only one eye Thin cornea or keratoconus Any disease that can delay wound healing, such as diabetes or chronic diseases Intolerance to any of the components of the studied drugs Use of systemic non-steroidal anti-inflammatory drugs during the study period The need to use topical eye drops before surgery (such as glaucoma or allergic drops) dry eyes History of herpes zoster or herpes simplex keratitis Pregnancy and breastfeeding

Design outcomes

Primary

Measure	Time frame
Evaluation of the pain level of patients after refractive surgery. Timepoint: Days 1, 3, 5 and 7 after the operation. Method of measurement: 10-point visual analog scale.;Evaluation of the photophobia level of patients after refractive surgery. Timepoint: Days 1, 3, 5 and 7 after the operation. Method of measurement: 10-point visual analog scale.;Evaluation of the eye burning level of patients after refractive surgery. Timepoint: Days 1, 3, 5 and 7 after the operation. Method of measurement: 10-point visual analog scale.;Evaluation of the eye itching level of patients after refractive surgery. Timepoint: Days 1, 3, 5 and 7 after the operation. Method of measurement: 10-point visual analog scale.;Evaluation of the foreign body sensation of patients after refractive surgery. Timepoint: Days 1, 3, 5 and 7 after the operation. Method of measurement: 10-point visual analog scale.	—

Measure

Time frame

Evaluation of the pain level of patients after refractive surgery. Timepoint: Days 1, 3, 5 and 7 after the operation. Method of measurement: 10-point visual analog scale.;Evaluation of the photophobia level of patients after refractive surgery. Timepoint: Days 1, 3, 5 and 7 after the operation. Method of measurement: 10-point visual analog scale.;Evaluation of the eye burning level of patients after refractive surgery. Timepoint: Days 1, 3, 5 and 7 after the operation. Method of measurement: 10-point visual analog scale.;Evaluation of the eye itching level of patients after refractive surgery. Timepoint: Days 1, 3, 5 and 7 after the operation. Method of measurement: 10-point visual analog scale.;Evaluation of the foreign body sensation of patients after refractive surgery. Timepoint: Days 1, 3, 5 and 7 after the operation. Method of measurement: 10-point visual analog scale.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactAmirreza Farsiani

Zanjan University of Medical Sciences

amirrezafarsiani@zums.ac.ir+98 24 3336 9916

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026