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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2009 by L.V. Prasad Eye Institute.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
L.V. Prasad Eye Institute
ClinicalTrials.gov Identifier:
NCT01023113
First received: December 1, 2009
Last updated: NA
Last verified: December 2009
History: No changes posted
  Purpose

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


Condition Intervention
Macular Edema
Diabetic Retinopathy
Visual Field Loss
Procedure: PASCAL laser
Procedure: Conventional laser

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: To Compare Visual Field Impairment in Conventional Double Frequency Nd: YAG Panretinal Photocoagulation With PASCAL Panretinal Photocoagulation

Resource links provided by NLM:


Further study details as provided by L.V. Prasad Eye Institute:

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 [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Effect on macular edema in terms of OCT thickness [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: September 2009
Estimated Study Completion Date: March 2010
Estimated Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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 by PASCAL laser
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
Active Comparator: 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 by conventional laser
Procedure: 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

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

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
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01023113

Contacts
Contact: Nand Kishore, M.D. 04030612607 narayanan@lvpei.org

Locations
India
LV Prasad Eye Institute Recruiting
Hyderabad, A.p., India, 500034
Contact: Nand Kishore, M.D.    04030612607    narayanan@lvpei.org   
Principal Investigator: Raja Narayanan, M.D.         
Sponsors and Collaborators
L.V. Prasad Eye Institute
  More Information

No publications provided

Responsible Party: LVPrasad Eye Institute Hyderabad, Same as above
ClinicalTrials.gov Identifier: NCT01023113     History of Changes
Other Study ID Numbers: nand2010
Study First Received: December 1, 2009
Last Updated: December 1, 2009
Health Authority: India: Ethics committee, LV Prasad Eye Institute

Keywords provided by L.V. Prasad Eye Institute:
Diabetic retinopathy
laser
field loss
macular edema
Visual field loss

Additional relevant MeSH terms:
Diabetic Retinopathy
Edema
Macular Edema
Retinal Diseases
Scotoma
Eye Diseases
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Signs and Symptoms
Macular Degeneration
Retinal Degeneration
Vision Disorders
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases

ClinicalTrials.gov processed this record on August 18, 2014