To study the antinfiammatory effect of topical NSAID as an adjunct topical steroid versus a topical steroid alone in patients with pseudo exfoliation (PEX) syndrome after cataract surgery.
Design
Patients who have a significant cataract with PEX and are candidate for phaco surgery will be randomly (random block) devided into 2 groups of 46 subjects with a single-blind allocation.
Group 1: Patients who receive corticosteroid and antibiotic eye drops will also receive the ketorolac eye drop every 6 hours for 2 weeks.
Group 2: Patients receiving betamethasone eye drops every 4 hours and chlobiotic every 6 hours.
Settings and conduct
The study will be done in eye clinic of Amiralmomenin Hospital in Rasht.
In this study only patients will be blind. Addition of ketorolac eye drop will not be explained to the patients .
Participants/Inclusion and exclusion criteria
Inclusion criteria:
- Patients diagnosed with significant cataracts (Grade 3 and above) who have pseudoexfoliation in slit lamp examination;
- Patients who have not used oral, topical or inhaled NSAIDs for a week before surgery;
- Patients who have not used topical, inhaled, or systemic corticosteroids for 15 days before surgery;
- Patients who have known hypersensitivity to any component of the NSAIDs;
Non-inclusion criteria:
- Patients with a history of uncontrolled chronic ocular or systemic disease; a history of ocular inflammation and trauma in the eye under study;
- Intraoperative complications such as rupture of posterior capsule and vitreous loss during cataract surgery;
- Patients with cataract surgery using either extracapsular cataract extraction or intracapsular cataract extraction method;
- Patients with extensive postoperative ocular inflammation who need systemic anti-inflammatory drugs;
Intervention groups
Group 1 (Interventional Group): In addition to routine care (chloramphenicol eye drops every 6 hours and betamethasone eye drops every 4 hours until a one month after surgery), ketorolac (Sinarolac 0.5%) is taken every 6 hours for 15 days.
Group 2 (Control Group): Patients who receive routine care including chloramphenicol eye drops every 6 hours and betamethasone eye drops every 4 hours until one month after surgery.
Main outcome variables
anterior chamber inflammation grade
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160919029871N3
Registration date:2018-03-02, 1396/12/11
Registration timing:registered_while_recruiting
Last update:2018-03-02, 1396/12/11
Update count:0
Registration date
2018-03-02, 1396/12/11
Registrant information
Name
Mita Akbari
Name of organization / entity
Guilan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 13 3323 6886
Email address
mitra.akbari@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-01-21, 1396/11/01
Expected recruitment end date
2019-06-22, 1398/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The role of topical NSAIDs on inflammation and anterior segment complications after cataract surgery in patients with pseudoexfoliation syndrome
Public title
Topical nonsteroidal anti-inflammatory drug effect on patients with pseudoexfoliation syndrome during cataract surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Having Significant cataract (grade 3 and higher) and clinical signs of PEX.
The patient should not be used systemic or inhaled NSAIDs within 1 week before surgery and the patients should not use the inhaled or systemic corticosteroids within 15 days after surgery
Exclusion criteria:
Having known hypersensitivity to any components of the NSAIDs
uncontrolled chronic ocular or systemic inflammatory disease; a history of eye trauma and any retinal and macular disease, any intraocular complication during surgery (vitreous loss)
The patient who must be treated with systemic anti-inflammatory medications for extensive inflammation following cataract surgery
Age
From 40 years old to 95 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Sample size
Target sample size:
96
Randomization (investigator's opinion)
Randomized
Randomization description
Patients with cataract and clinical signs of PEX are randomly assigned into 2 groups through block randomization using blocks of size 4.
Group 1: all medication in group 1 plus eye drop Ketorolac every 6 hours until 2 weeks.
Group 2: Betamethasone eye drops every 4 hours and Chlobiotic every 6 hours
Blinding (investigator's opinion)
Single blinded
Blinding description
Addition of ketorolac eye drops will not be explained to the patient.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committe of Guilan University of Medical Sciences
Street address
Eye Research Center,Amiralmomenin Hospital, 17 Shahrivar st,Rasht
City
Rasht
Province
Guilan
Postal code
41396-37459
Approval date
2017-12-31, 1396/10/10
Ethics committee reference number
IR.GUMS.REC.1396.415
Health conditions studied
1
Description of health condition studied
Anterior segment inflammation and complications after cataract surgery in patients with pseudoexfoliation syndrome
ICD-10 code
H25
ICD-10 code description
Age-related cataract
Primary outcomes
1
Description
Percentage of subjects with anterior chamber inflammation based on cell count (CELL) and percentage of subjects with anterior chamber inflammation based on protein content based on the rating of the San-working Group (0 to 4 degrees).
Timepoint
1, 3, 7 and 30 days after surgery
Method of measurement
Clinical examination
Secondary outcomes
1
Description
The degree of opacity of the anterior capsule (ACO) (grade 0-4) and degree of opacity of the posterior capsule (PCO) (grade 0-4).
Timepoint
1,3,6 months postoperatively
Method of measurement
photo slit examination
Intervention groups
1
Description
Interventional Group: In addition to routine care including chloramphenicol eye drops every 6 hours and betamethasone eye drops every 4 hours until one month after surgery, ketorolac (Sinarolac 0.5%) is taken every 6 hours for 15 days.
Category
Treatment - Drugs
2
Description
Control Group: Patients who receive routine care including chloramphenicol eye drops every 6 hours and betamethasone eye drops every 4 hours until one month after surgery.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Amiralmomenin Hospital
Full name of responsible person
Mitra Akbari
Street address
Eye Research Center, Amiralmomenin Hospital,17 Shahrivar St,Rasht
City
Rasht
Province
Guilan
Postal code
41396-37459
Phone
+98 13 3323 6886
Email
mitra.akbari20@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Guilan University of Medical Sciences
Full name of responsible person
Shadmen Nemati
Street address
Shahid Siadaty St, Namju St, Rasht
City
Rasht
Province
Guilan
Postal code
41446-66949
Phone
+98 13 3333 0862
Email
research@gums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Guilan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Guilan University of Medical Sciences
Full name of responsible person
Dr Mitra Akbari
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Ophthalmology
Street address
Eye Research Center, Amiralmomenin Hospital, 17 Shahrivar St,Rasht
City
Rasht
Province
Guilan
Postal code
41396-37459
Phone
+98 13 3323 6886
Email
mitra.akbari20@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Guilan University of Medical Sciences
Full name of responsible person
Dr Mitra Akbari
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Ophthalmology
Street address
Eye Research Center, Amiralmomenin Hospital, 17 Shahrivar St, Rasht
City
Rasht
Province
Guilan
Postal code
41396-37459
Phone
+98 13 3323 6886
Email
mitra.akbari20@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Guilan University of Medical Sciences
Full name of responsible person
Shila Kianmehr
Position
Researcher
Latest degree
Master
Other areas of specialty/work
Health Service Management
Street address
Eye Research Center, Amiralmomenin Hospital, 17 Shahrivar St, Rasht
City
Rasht
Province
Guilan
Postal code
41396-37459
Phone
+98 13 3323 6886
Email
shila.kianmehr@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD