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

25 Aug 2017

The date of last modification

Jan 28, 2019



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 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)


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


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

  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)

  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



State of Ethics Review Approval


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 & 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





Trial Completion details


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