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Clinical Trials/NCT01023113
NCT01023113UnknownNot Applicable

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

L.V. Prasad Eye Institute2 sites in 1 country60 target enrollmentStarted: September 2009Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Enrollment
60
Locations
2
Primary Endpoint
Comparison of the two methods in relation to visual field loss in terms of MD,CPSD and each quadrants loss of fields

Study Overview

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

  1. To compare visual field impairment in conventional double frequency Nd: YAG panretinal photocoagulation with PASCAL panretinal photocoagulation.
  2. 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

  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

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

Outcomes

Primary Outcomes

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 Outcomes

  • Effect on macular edema in terms of OCT thickness(3 months)

Investigators

Sponsor Class
Other

Study Sites (2)

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