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IRCT20220216054042N1 IRCT 2023-05-08 Esfahan University of Medical Sciences The effect of non-steroidal anti-inflammatory eye drops vs placebo on macular vessel density following phacoemulsification Comparison of the effect of ketorolac eye drops versus placebo on macular vessel density in cataract patients who underwent phacoemulsification 2023-05-05 anticipated 76 Complete https://irct.ir/trial/68146 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Balance Block Randomization, Blinding description: Patients receive medications in sealed envelopes that are coded. Coding will be done by one of the co-authors, and the prescribing physician, the evaluating physician, and the patient will be blinded. 3 Cataract, Phacoemulsification. Intervention 1: Intervention group: The intervention group patients will receive topical ketorolac drops (prescribed for its anti-inflammatory effects, not for pain relief) administered to the eye four times a day for a duration of three weeks. Each patient will likely require three ocular drops during three weeks. Intervention 2: Control group: The control group patients will receive topical artificial tears drops (tearlose) administered to the eye four times a day for a duration of three weeks. Each patient will likely require three ocular drops. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is This decision will be made after collecting the data
public Alireza Dehghani
Isfahan Province, Isfahan, Hezar Jerib Avenue
Isfahan Iran (Islamic Republic of) 8174673461 +98 31 3792 3876 dehghani@med.mui.ac.ir Esfahan University of Medical Sciences scientific Alireza Dehghani
Isfahan Province, Isfahan, Hezar Jerib Avenue
Isfahan Iran (Islamic Republic of) 8174673461 +98 31 3792 3876 dehghani@med.mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) Cataract patients who underwent phacoemulsification 18 years no limit Both Not consenting to participate in the study Age of fewer than 18 years History of eye disease affecting the optic nerve and macula History of intraocular surgery History of neurological diseases History of systemic diseases with ocular manifestations H25 Age-related cataract Treatment - Drugs Placebo Intervention group: The intervention group patients will receive topical ketorolac drops (prescribed for its anti-inflammatory effects, not for pain relief) administered to the eye four times a day for a duration of three weeks. Each patient will likely require three ocular drops during three weeks. Control group: The control group patients will receive topical artificial tears drops (tearlose) administered to the eye four times a day for a duration of three weeks. Each patient will likely require three ocular drops. Size of foveal avascular zone. Timepoint: 21 days after initiating the intervention. Method of measurement: Optical coherence tomography. Parafoveal vessel density. Timepoint: 21 days after initiating the intervention. Method of measurement: Optical coherence tomography. Esfahan University of Medical Sciences Approved 2023-04-11 Research ethics committee of Isfahan University of Medical Sciences Isfahan Province, Isfahan, Hezar Jerib Avenue Isfahan Isfehan Iran (Islamic Republic of)