To Compare Visual Field Impairment in Conventional Double Frequency Nd: YAG Panretinal Photocoagulation With PASCAL Panretinal Photocoagulation
Recruitment status was Recruiting
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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
- To compare visual field impairment in conventional double frequency Nd: YAG panretinal photocoagulation with PASCAL panretinal photocoagulation.
- 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 |
- 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 ]
- 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
- 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.
Out come Measure
- 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.
- 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 |
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.
Contacts and Locations| Contact: Nand Kishore, M.D. | 04030612607 | narayanan@lvpei.org |
| 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. | |
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:
|
Vision Disorders 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 Sensation Disorders Neurologic Manifestations Nervous System Diseases |
ClinicalTrials.gov processed this record on June 18, 2013