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To Compare Visual Field Impairment in Conventional Double Frequency Nd: YAG Panretinal Photocoagulation With PASCAL Panretinal Photocoagulation

Primary Purpose

Macular Edema, Diabetic Retinopathy, Visual Field Loss

Status
Unknown status
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
PASCAL laser
Conventional laser
Sponsored by
L.V. Prasad Eye Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Macular Edema focused on measuring Diabetic retinopathy, laser, field loss, macular edema, Visual field loss

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. 60 eyes of diabetic patients with proliferative DR will be included.
  2. Visual acuity 20/50 or better in all patients.
  3. Patients available for follow up at least twice between 4-12 weeks.
  4. Patients giving consent for panretinal photocoagulation and for inclusion in study

Exclusion Criteria:

  1. Patients with diseases known to affect visual field as such as aphakia, cataract, glaucoma, optic nerve and macular diseases, will be excluded from the study.
  2. Previous photocoagulation(macular laser or PRP) will also be an exclusion criterion.

Sites / Locations

  • LV Prasad Eye InstituteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

PASCAL laser, PRP in 2-3 sitting at 3 days interval.

Conventional laser

Arm Description

PRP will be completed in 2-3 sitting at 3 days interval with one spots apart and moderate intensity gray burns will be given between arcade to periphery by PASCAL laser

PRP will be completed in 2-3 sitting at 3 days interval with one spots apart and moderate intensity gray burns will be given between arcade to periphery by conventional laser

Outcomes

Primary Outcome Measures

Comparison of the two methods in relation to visual field loss in terms of MD,CPSD and each quadrants loss of fields

Secondary Outcome Measures

Effect on macular edema in terms of OCT thickness

Full Information

First Posted
December 1, 2009
Last Updated
December 1, 2009
Sponsor
L.V. Prasad Eye Institute
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1. Study Identification

Unique Protocol Identification Number
NCT01023113
Brief Title
To Compare Visual Field Impairment in Conventional Double Frequency Nd: YAG Panretinal Photocoagulation With PASCAL Panretinal Photocoagulation
Official Title
To Compare Visual Field Impairment in Conventional Double Frequency Nd: YAG Panretinal Photocoagulation With PASCAL Panretinal Photocoagulation
Study Type
Interventional

2. Study Status

Record Verification Date
December 2009
Overall Recruitment Status
Unknown status
Study Start Date
September 2009 (undefined)
Primary Completion Date
February 2010 (Anticipated)
Study Completion Date
March 2010 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
L.V. Prasad Eye Institute

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Lacunae in Knowledge No study is available in literature regarding visual field impairment in proliferative diabetic retinopathy comparing conventional double frequency Nd:YAG panretinal photocoagulation with PASCAL panretinal photocoagulation AIMS & OBJECTIVE To compare visual field impairment in conventional double frequency Nd: YAG panretinal photocoagulation with PASCAL panretinal photocoagulation. To examine the effect of these modalities of laser on macular edema 60 eyes of proliferative diabetic retinopathy will undergo humphery visual field analysis,and optical coherence tomography before and after panretinal photocoagulation
Detailed Description
Material and Methods 1.Study will be prospective randomized interventional case series. Methods: 60 eyes of proliferative diabetic retinopathy (clear media with no vitreous/significant preretinal hemorrhage) will be taken for the study, out of which 30 eyes will undergo panretinal photocoagulation by conventional frequency doubled Nd: YAG laser and remaining 30 eyes will be by PASCAL laser. All patients will undergo routine ophthalmic examination (visual acuity, slit lamp, indirect ophthalmoscope, IOP) as well as FFA/seven fields fundus photos (whenever required), OCT(optoview spectral domain OCT), visual fields (Humphrey 30-2 SITA Standard and 60-1) and baseline blood investigation will be done before 1st sitting of laser. Written informed consent will be taken by all the subjects. PRP will be completed in 2-3 sitting at 3 days interval with one spots apart and moderate intensity gray burns will be given between arcade to periphery. In case of clinical significant macular edema modified grid/ focal laser of mild intensity spots will be done. At each visit patient will be assessed for visual acuity, OCT, IOP (applanation tonometer). Patients will be followed up for at least 3 months. After the completion of last sitting of photocoagulation, follow-up will be at one month and 3 months. At one month follow up together with routine ophthalmic examination, OCT, HVF 30-2,60-1 will be done. At final follow-up at 3 months HVF 30-2,60-1,OCT will be done in addition of routine ophthalmic examination and FFA will be done whenever indicated. Inclusion Criteria 60 eyes of diabetic patients with proliferative DR will be included. Visual acuity 20/50 or better in all patients. Patients available for follow up at least twice between 4-12 weeks. Patients giving consent for panretinal photocoagulation and for inclusion in study Exclusion Criteria Patients with diseases known to affect visual field as such as aphakia, cataract, glaucoma, optic nerve and macular diseases, will be excluded from the study. Previous photocoagulation(macular laser or PRP) will also be an exclusion criterion. Out come Measure Comparison of the two methods in relation to visual field loss(in previous studies average deterioration in visual field(MD) was 3-5dB in 45% cases) in terms of MD,CPSD and each quadrants loss of fields and number of patients worsened the visual fields and which method will be superior in term of less visual field loss. Effect on macular edema in terms of OCT thickness

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Macular Edema, Diabetic Retinopathy, Visual Field Loss
Keywords
Diabetic retinopathy, laser, field loss, macular edema, Visual field loss

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
PASCAL laser, PRP in 2-3 sitting at 3 days interval.
Arm Type
Experimental
Arm Description
PRP will be completed in 2-3 sitting at 3 days interval with one spots apart and moderate intensity gray burns will be given between arcade to periphery by PASCAL laser
Arm Title
Conventional laser
Arm Type
Active Comparator
Arm Description
PRP will be completed in 2-3 sitting at 3 days interval with one spots apart and moderate intensity gray burns will be given between arcade to periphery by conventional laser
Intervention Type
Procedure
Intervention Name(s)
PASCAL laser
Intervention Description
PRP will be completed in 2-3 sitting at 3 days interval with one spots apart and moderate intensity gray burns will be given between arcade to periphery
Intervention Type
Procedure
Intervention Name(s)
Conventional laser
Intervention Description
PRP will be completed in 2-3 sitting at 3 days interval with one spots apart and moderate intensity gray burns will be given between arcade to periphery
Primary Outcome Measure Information:
Title
Comparison of the two methods in relation to visual field loss in terms of MD,CPSD and each quadrants loss of fields
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Effect on macular edema in terms of OCT thickness
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 60 eyes of diabetic patients with proliferative DR will be included. Visual acuity 20/50 or better in all patients. Patients available for follow up at least twice between 4-12 weeks. Patients giving consent for panretinal photocoagulation and for inclusion in study Exclusion Criteria: Patients with diseases known to affect visual field as such as aphakia, cataract, glaucoma, optic nerve and macular diseases, will be excluded from the study. Previous photocoagulation(macular laser or PRP) will also be an exclusion criterion.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nand Kishore, M.D.
Phone
04030612607
Email
narayanan@lvpei.org
Facility Information:
Facility Name
LV Prasad Eye Institute
City
Hyderabad
State/Province
A.p.
ZIP/Postal Code
500034
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nand Kishore, M.D.
Phone
04030612607
Email
narayanan@lvpei.org
First Name & Middle Initial & Last Name & Degree
Raja Narayanan, M.D.

12. IPD Sharing Statement

Learn more about this trial

To Compare Visual Field Impairment in Conventional Double Frequency Nd: YAG Panretinal Photocoagulation With PASCAL Panretinal Photocoagulation

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