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

Diabetic Retinopathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01023113
• Other study ID #: nand2010
• 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

Related Conditions & MeSH terms

• Diabetic Retinopathy
• Macular Edema
• Retinal Diseases
• Visual Field Loss

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