Home » Trials » SLCTR/2017/027


Dysphotopsia following cataract surgery; clinical trial on a preventive surgical approach -

SLCTR Registration Number

SLCTR/2017/027


Date of Registration

25 Aug 2017

The date of last modification

Aug 25, 2017



Application Summary


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 of Health Condition(s) Studied

Cataract and dysphotopsia


Scientific Acronym

None


Public Acronym

None


Brief title

None


Universal Trail Number

U1111-1197-6240


Any other number(s) assigned to the trial and issuing authority

P/122/04/2017 (ERC: Kelaniya)


Trial Details


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


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

  1. Cataract diagnosed by slit lamp examination by consultant eye surgeon.
  2. Should be cataract with no complications
  3. Patients above 40 years
  4. Both genders

Exclusion criteria

Patients with corneal pathologies, astigmatism or any other ocular pathology.



Primary outcome(s)

Achieving a reduction in incidence of dysphotopsia (according to patient perception) following cataract surgery. This will be assessed using an interviewer administered questionnaire.


Primary outcome(s) - Time of assessment(s)

Post op day 1, 3 weeks and 3 months


Secondary outcome

None


Secondary outcome(s) - Time of assessment(s)

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


Recruitment status

Pending


State of ethics review approval

Approved by the Ethics Review Committee, Faculty of Medicine, University of Kelaniya on 17.05.2017 (Ref: P/122/04/2017)


Funding source

None (investigator funded)



Contact & Sponsor Information


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


Primary study sponsor/organization

Faculty of Medicine, University of Kelaniya,

PO Box 6, Thalagolla road, Ragama, Sri Lanka
112961267
112958337

Secondary study sponsor (If any)

None