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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01023113
Other study ID # nand2010
Secondary ID
Status Recruiting
Phase N/A
First received December 1, 2009
Last updated December 1, 2009
Start date September 2009
Est. completion date March 2010

Study information

Verified date December 2009
Source L.V. Prasad Eye Institute
Contact Nand Kishore, M.D.
Phone 04030612607
Email narayanan@lvpei.org
Is FDA regulated No
Health authority India: Ethics committee, LV Prasad Eye Institute
Study type Interventional

Clinical Trial 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


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

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.

Out come Measure

1. 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.

2. Effect on macular edema in terms of OCT thickness


Recruitment information / eligibility

Status Recruiting
Enrollment 60
Est. completion date March 2010
Est. primary completion date February 2010
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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 ?eld 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment


Intervention

Procedure:
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
Conventional 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

Locations

Country Name City State
India LV Prasad Eye Institute Hyderabad A.p.

Sponsors (1)

Lead Sponsor Collaborator
L.V. Prasad Eye Institute

Country where clinical trial is conducted

India, 

Outcome

Type Measure Description Time frame Safety issue
Primary Comparison of the two methods in relation to visual field loss in terms of MD,CPSD and each quadrants loss of fields 3 months No
Secondary Effect on macular edema in terms of OCT thickness 3 months No
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