Comparison of effect of Cyclosporine ophthalmic emulsion 2% and Betamethasone eye drop on intraocular pressure, conjunctival hyperemia and subjective dry eye symptoms following trabeculectomy in primary open angle glaucoma (POAG) patinets.
Objectives: to compare effects of cyclosporine 2% and betamethasone eye drops on surgical results of trabeculectomy in primary open angle glaucoma patients.
Design: triple blind, prospective randomized clinical trial
Setting and Conduct: the study takes place in Eye Research Center, Mashhad University of Medical Sciences. In appropriate subjects according to the study criteria, a standard trabeculectomy will be done. In first postoperative day and according to a random digit table, the patients will be allocated in group A or B. A pharmaceutical company, would provide the cyclosporine 2% and betamethasone eye drops in similar bottles with blinded labels (A or B) and disclose the content of each bottle only at the conclusion of study. The patients and researchers are masked to the study groups.
Participants: Patients with primary open angle glaucoma with uncontrolled intraocular pressure or progressive disease, despite maximally tolerable medical therapy, would be included in the study. The following exclusion criteria will be respected: age<20 years; previous surgery in same eye; candidate for combined surgery; pregnancy; breast feeding; monocular subjects; allergy to eye drops.
Intervention: following surgery and allocation to the study groups, monthly observation of clinical status will be done. In each visit a complete set of ophthalmic examinations along with slit-lamp photography of bleb area will be done.
Main outcome measures: intraocular pressure; dry eye symptoms; bleb morphology (IBAGS)
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138706111154N1
Registration date:2013-09-23, 1392/07/01
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-09-23, 1392/07/01
Registrant information
Name
Ramin Danehvar
Name of organization / entity
Eye Research Center, Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 1728 1401
Email address
daneshvarr@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research, Mashhad University of Medical Sciences
Expected recruitment start date
2013-09-11, 1392/06/20
Expected recruitment end date
2015-01-10, 1393/10/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of effect of Cyclosporine ophthalmic emulsion 2% and Betamethasone eye drop on intraocular pressure, conjunctival hyperemia and subjective dry eye symptoms following trabeculectomy in primary open angle glaucoma (POAG) patinets.
Public title
A study to evaluate the effect of cyclosporine 2% eye drop on surgical result of glaucoma surgery (trabeculectomy)
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria: POAG patient with insufficient IOP control on maximal tolerable medical therapy (MTMT), undergoing primary trabeculectomy with MMC augmentation.
Exclusion Criteria: Age <20 years; History of previous ocular surgery in the same eye; Candidate for combined surgery; Pregnancy; Breast feeding; Monocular subject; Allergy to any topical antiglaucoma medication, or cyclosporine
Age
From 20 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee, Mashhad University of Medical Sciences
Street address
Ghoreishi building, Daneshgah street
City
Mashhad
Postal code
91375345
Approval date
2013-08-17, 1392/05/26
Ethics committee reference number
911251
Health conditions studied
1
Description of health condition studied
glaucoma
ICD-10 code
H40.1
ICD-10 code description
Primary Open-Angle Glaucoma
Primary outcomes
1
Description
intraocular pressure (IOP)
Timepoint
monthly
Method of measurement
Goldmann applanation tonometer (GAT)
2
Description
bleb morphology
Timepoint
monthly
Method of measurement
clinical observation and slit photography (IBAGS)
3
Description
Subjective dry eye symptoms
Timepoint
monthly
Method of measurement
questionnaire
Secondary outcomes
1
Description
success rate
Timepoint
Mid-term success rate (6 month following surgery) would be evaluated.
Method of measurement
clinical exam
2
Description
complication rate
Timepoint
Midterm complication rate (6 month following surgery) would be evaluated.
Method of measurement
clinical exam
3
Description
visual acuity
Timepoint
monthly
Method of measurement
clinical exam (logMAR)
Intervention groups
1
Description
Case Group: In the first postoperative day following a standard, fornix-based trabeculectomy, ophthalmic emulsion of cyclosporine A, 2%, every 4 hours for the first postoperative week and every 6 hours for the next 3 weeks will be prescribed for the patients.
Category
Treatment - Drugs
2
Description
Control Group: In the first postoperative day following a standard, fornix-based trabeculectomy, betamethasone eye drop, every 4 hours for the first postoperative week and every 6 hours for the next 3 weeks will be prescribed for the patients.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Eye Research Center, Mashhad University of Medical Sciences
Full name of responsible person
Ramin Daneshvar, MD
Street address
Khatam Eye Hospital, Gharani Blvd.
City
Mashhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research, Mashhad University of Medical Sciences
Full name of responsible person
Dr. Ramezani
Street address
Ghoreishi Building, Daneshgah Street
City
Mashhad,
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, Mashhad 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
Eye Research Center, Mashhad University of Medical Sciences
Full name of responsible person
Parisa Rajaei; Marzieh Saadat
Position
Research Secreterist
Other areas of specialty/work
Street address
Khatam Anbia Eye Hospital, Gharani Blvd
City
Mashhad
Postal code
91959-61151
Phone
+98 51 1728 9911
Fax
Email
erc@mums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Eye Research Center, Mashhad University of Medical Sciences
Full name of responsible person
Ramin Daneshvar, MD
Position
Assistant Professor of Ophthalmology; Fellowship in Glaucoma; MD
Other areas of specialty/work
Street address
Khatam Anbia Eye Hospital, Gharani Blvd.,
City
Mashhad
Postal code
91959-61151
Phone
+98 51 1728 9911
Fax
Email
radaneshvar@gmail.com; daneshvarr@mums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Eye Research Center, Mashhad University of Medical Sciecnes
Full name of responsible person
Ramin Daneshvar, MD
Position
Assistant Professor of Ophthalmology, Glaucoma Fellowship, MD
Other areas of specialty/work
Street address
Khatam Anbia Eye Hospital, Gharani Blvd.,
City
Mashhad
Postal code
91959-61151
Phone
+98 51 1728 9911
Fax
+98 51 1728 9911
Email
radaneshvar@gmail.com; daneshvarr@mums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)