This study is a Randomized controlled trial in Farabi Eye Hospital on glaucomatous patients under prostaglandin analogue medication treatment who undergo cataract surgery. The goal of the study is determining the role of prostaglandin analogues in CME incidence after cataract surgery. All glaucomatous patients under Latanaprost with negative history of uveitis and retinal diseases will be assessed by SD-OCT imaging before surgery. Patients would be excluded if have abnormal OCT before surgery or complicated cataract surgery. In this study, 100 patients will be randomized into two groups by block randomization. In the first group Latanaprost is continued and in the second group Latanaprost is replaced with other antiglaucoma medications. Drug prescription is double blinded. One month and three months after surgery, patients will be assessed again by SD-OCT imaging and the risk of CME incidence (as the main outcome) and the visual acuity and the intraocular pressure (as secondary outcomes) will be evaluated in these two groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016081329326N1
Registration date:2016-09-11, 1395/06/21
Registration timing:registered_while_recruiting
Last update:
Update count:3
Registration date
2016-09-11, 1395/06/21
Registrant information
Name
Seyed Masoud Mirghorbani
Name of organization / entity
Farabi Eye Hospital, Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 5540 0003
Email address
m-mirghorbani@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Tehran University of Medical Sciences
Expected recruitment start date
2016-03-19, 1394/12/29
Expected recruitment end date
2018-09-21, 1397/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Incidence of Cystoid Macular Edema (CME) following prostaglandin analogue use after uncomplicated cataract surgery in glaucoma patients
Public title
Effect of Latanaprost eye drop on retina after cataract surgery in glaucoma patients
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Glaucoma patients under prostaglandin analogues who need cataract surgery; Age over 18; No history of intraocular surgery, intravitreal injections, or retinal laser; No history of trauma; No non-glaucomatous optic neuropathy; No high myopia; No history of diabetic retinopathy, AMD, Uveitis, RD, ERM, and retinal vascular disorders; No occurrence of CME in the other eye following previous cataract surgery
Exclusion Criteria: Existence of cyst in macula in preop OCT; Complicated cataract surgery (posterior capsular rupture or vitreous loss)
Age
From 18 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Randomization is done by Block randomization method.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences
Street address
Farabi Eye Hospital, Qazvin sq, South Kargar st
City
Tehran
Postal code
1336616351
Approval date
2016-08-06, 1395/05/16
Ethics committee reference number
IR.TUMS.FARABIH.REC.1395.397
Health conditions studied
1
Description of health condition studied
Cystoid macular edema
ICD-10 code
H35.8
ICD-10 code description
Other specified retinal disorders
Primary outcomes
1
Description
Central Macular Thickness
Timepoint
Before intervention, 1 month after intervention and 3 months after intervention
Method of measurement
Using OCT-SD imaging
Secondary outcomes
1
Description
Intraocular pressure
Timepoint
Before intervention, 1 month after intervention and 3 months after intervention
Method of measurement
Goldmann tonometry
2
Description
Visual acuity
Timepoint
Before intervention, 1 month after intervention and 3 months after intervention
Method of measurement
Snellen chart
Intervention groups
1
Description
Intervention group : In this group, prostaglandin analogue (Latanaprost eye drop) is discontinued immediately after cataract surgery for 3 months and replaced with other antiglaucoma agents to control IOP.
Category
Treatment - Drugs
2
Description
Control group: Prostaglandin analogue (Latanaprost eye drop, one drop before sleep at night) after cataract surgery will be continued.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Farabi Eye Hospital
Full name of responsible person
Street address
Farabi Eye Hospital, Qazvin sq, South Kargar st
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Tehran University of Medical Sciences
Full name of responsible person
Neda Bina
Street address
Vice chancellor for research, Tehran University of Medical Sciences central building, Qods St, Keshavarz Av
City
Tehran
Grant name
-
Grant code / Reference number
-
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Farabi Eye Hospital, Tehran University of Medical Sciences