Home » Trials » SLCTR/2017/027
Dysphotopsia following cataract surgery; clinical trial on a preventive surgical approach
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SLCTR Registration Number
SLCTR/2017/027
Date of Registration
The date of last modification
Mar 03, 2019
Scientific Title of Trial
Dysphotopsia following cataract surgery; clinical trial on a preventive surgical approach
Public Title of Trial
Clinical trial on prevention of a type of visual disturbance (Dysphotopsia) following cataract surgery.
Disease or Health Condition(s) Studied
Cataract and dysphotopsia
Scientific Acronym
None
Public Acronym
None
Brief title
None
Universal Trial Number
U1111-1197-6240
Any other number(s) assigned to the trial and issuing authority
P/122/04/2017 (ERC: Kelaniya)
What is the research question being addressed?
What is the effect of the position of intra ocular lens on the incidence of dysphotopsia following cataract surgery?
Type of study
Interventional
Study design
Allocation
Randomized controlled trial
Masking
Double blinded
Control
Active
Assignment
Parallel
Purpose
Other
Study Phase
Not Applicable
Intervention(s) planned
Setting- Sri Jayawadenapura hospital and Hemas hospital, Wattala Participants will be allocated using simple randomization Arm 1 – intra ocular lens placed at 45 degrees Arm 2 – intraocular lens placed at 90 degrees Arm 3 – intraocular lens placed at 180 degrees Each arm will be supported with all the standard post operative care. No specific care is will be given. Participants and data collectors will be blinded about the lens position
Inclusion criteria
Exclusion criteria
Patients with corneal pathologies, astigmatism or any other ocular pathology.
Primary outcome(s)
|
1.
Achieving a reduction in incidence of dysphotopsia (according to patient perception) following cataract surgery. This will be assessed using an interviewer administered questionnaire. |
[ Post op day 1, 3 weeks and 3 months ] |
Secondary outcome(s)
|
1.
None |
[ None ] |
Target number/sample size
278 (139 in each arm)
Countries of recruitment
Sri Lanka
Anticipated start date
2017-09-01
Anticipated end date
2017-12-07
Date of first enrollment
Date of study completion
Recruitment status
Pending
Funding source
None (investigator funded)
Regulatory approvals
Not applicable
Status
Approved
Date of Approval
2017-05-17
Approval number
P/122/04/2017
Details of Ethics Review Committee
| Name: | Ethics Review Committee, Faculty of Medicine, University of Kelaniya |
| Institutional Address: | PO Box 6, Thalagolla Road, Ragama Sri Lanka |
| Telephone: | +94-11-2961267 |
| Email: | erckelaniya@gmail.com |
Contact person for Scientific Queries/Principal Investigator
Dr. Salvin KA
Consultant Eye Surgeon, Senior Lecturer
Department of Anatomy,
Faculty of Medicine, University of Kelaniya,
Ragama, Sri Lanka
0112961267
0777356191
salvin@kln.ac.lk
Contact Person for Public Queries
Dr. Salvin KA
Consultant Eye Surgeon, Senior Lecturer
Department of Anatomy,
Faculty of Medicine, University of Kelaniya,
Ragama, Sri Lanka
0112961267
0777356191
salvin@kln.ac.lk
Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?
IPD sharing plan description
Not Available
Study protocol available
Protocol version and date
Not Available
Protocol URL
Not Available
Results summary available
No
Date of posting results
Date of study completion
Final sample size
Date of first publication
Link to results
Brief summary of results
