Determining and comparison of the effect of ketorolac eye drops versus placebo on macular vessel density in cataract patients who underwent phacoemulsification
Design
A controlled clinical trial, two parallel groups design, double-blind, randomized, phase 3 on 76 patients
Settings and conduct
This study will be conducted on adult patients who undergo phacoemulsification in Isfahan Feiz Hospital. After selecting eligible patients and obtaining written informed consent for participation, Patients will be randomly assigned in a 1:1 ratio to one of two intervention and control groups. Before prescribing the drug, each patient's demographic and clinical characteristics will be recorded. After the intervention, both groups will undergo optical coherence tomography (OCT), and the findings related to macular vessel density will be recorded.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Cataract patients who underwent phacoemulsification
Exclusion criteria: 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
Intervention groups
Patients in the intervention group will receive topical ketorolac eye every six hours for three weeks. Control group patients will be prescribed a placebo eye drop with the same intervals as the intervention group. The routine treatment is a topical corticosteroid, which all patients will receive.
Main outcome variables
Size of foveal avascular zone (mm2)
Vascular density of the parafovea (%)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220216054042N1
Registration date:2023-05-08, 1402/02/18
Registration timing:registered_while_recruiting
Last update:2023-05-08, 1402/02/18
Update count:0
Registration date
2023-05-08, 1402/02/18
Registrant information
Name
Atefeh Pirmoradian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3420 7040
Email address
atefeh.pirmoradian69@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-05-05, 1402/02/15
Expected recruitment end date
2024-03-05, 1402/12/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of ketorolac eye drops versus placebo on macular vessel density in cataract patients who underwent phacoemulsification
Public title
The effect of non-steroidal anti-inflammatory eye drops vs placebo on macular vessel density following phacoemulsification
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Cataract patients who underwent phacoemulsification
Exclusion criteria:
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
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Outcome assessor
Sample size
Target sample size:
76
Randomization (investigator's opinion)
Randomized
Randomization description
Balance Block Randomization
Blinding (investigator's opinion)
Double blinded
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
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research ethics committee of Isfahan University of Medical Sciences
Street address
Isfahan Province, Isfahan, Hezar Jerib Avenue
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2023-04-11, 1402/01/22
Ethics committee reference number
IR.MUI.MED.REC.1400.680
Health conditions studied
1
Description of health condition studied
Cataract, Phacoemulsification
ICD-10 code
H25
ICD-10 code description
Age-related cataract
Primary outcomes
1
Description
Size of foveal avascular zone
Timepoint
21 days after initiating the intervention
Method of measurement
Optical coherence tomography
2
Description
Parafoveal vessel density
Timepoint
21 days after initiating the intervention
Method of measurement
Optical coherence tomography
Secondary outcomes
empty
Intervention groups
1
Description
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.
Category
Treatment - Drugs
2
Description
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.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Feiz hospital
Full name of responsible person
Alireza Dehghani
Street address
Modarres St., Ghods Sq., Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3445 2031
Email
dehghani@med.mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Alireza Dehghani
Street address
Isfahan Province, Isfahan, Hezar Jerib Avenue
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 3876
Email
dehghani@med.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?