NCT01023113

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. 1.To compare visual field impairment in conventional double frequency Nd: YAG panretinal photocoagulation with PASCAL panretinal photocoagulation.
  2. 2.To examine the effect of these modalities of laser on macular edema

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2009

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2009

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 1, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 2, 2009

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2010

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2010

Completed
Last Updated

December 2, 2009

Status Verified

December 1, 2009

Enrollment Period

5 months

First QC Date

December 1, 2009

Last Update Submit

December 1, 2009

Conditions

Keywords

Diabetic retinopathylaserfield lossmacular edemaVisual field loss

Outcome Measures

Primary Outcomes (1)

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

    3 months

Secondary Outcomes (1)

  • Effect on macular edema in terms of OCT thickness

    3 months

Study Arms (2)

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

EXPERIMENTAL

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

Procedure: PASCAL laser

Conventional laser

ACTIVE COMPARATOR

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

Procedure: Conventional laser

Interventions

PASCAL laserPROCEDURE

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

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

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

Conventional laser

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

LV Prasad Eye Institute

Hyderabad, A.P., 500034, India

RECRUITING

MeSH Terms

Conditions

Macular EdemaDiabetic Retinopathy

Condition Hierarchy (Ancestors)

Macular DegenerationRetinal DegenerationRetinal DiseasesEye DiseasesDiabetic AngiopathiesVascular DiseasesCardiovascular DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System Diseases

Central Study Contacts

Nand Kishore, M.D.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 1, 2009

First Posted

December 2, 2009

Study Start

September 1, 2009

Primary Completion

February 1, 2010

Study Completion

March 1, 2010

Last Updated

December 2, 2009

Record last verified: 2009-12

Locations