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Changes in Macular Thickness After Patterns Scan Laser

Primary Purpose

Non Proliferative Diabetic Retinopathy., Proliferative Diabetic Retinopathy.

Status
Unknown status
Phase
Phase 4
Locations
Mexico
Study Type
Interventional
Intervention
Panretinal photocoagulation with PASCAL system
Sponsored by
Asociación para Evitar la Ceguera en México
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non Proliferative Diabetic Retinopathy. focused on measuring Pattern Scan Laser., Photocoagulation., Diabetic retinopathy treatment., Laser treatment

Eligibility Criteria

25 Years - 95 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients older than 25 years, with a diagnosis of severe NPDR or PRD.
  • Good pupil mydriasis (minimum 5mm) With clear media
  • Patients without previous laser treatment or treatment with antiangiogenic drug.

Exclusion Criteria:

  • Patients who do not accept informed consent.
  • Patients with clinical macular Edema before treatment.
  • Significant corneal opacity.
  • Patients with other eye diseases that interfere with the studies required for the monitoring of patients.
  • History of refractive surgery, glaucoma or ocular hypertension, intraocular inflammation, choroiditis multifocal, retinal detachment, optic neuropathy (4).
  • Patients with tractional retinal detachment due to abundant fibrovascular tissue. Or important fibrovascular tissue that fold or detach the retina.

Sites / Locations

  • Asociaciòn para Evitar la Ceguera en MèxicoRecruiting

Outcomes

Primary Outcome Measures

Retinal thickness after treatment

Secondary Outcome Measures

Full Information

First Posted
November 22, 2007
Last Updated
November 23, 2007
Sponsor
Asociación para Evitar la Ceguera en México
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1. Study Identification

Unique Protocol Identification Number
NCT00563628
Brief Title
Changes in Macular Thickness After Patterns Scan Laser
Official Title
Pattern Scan Laser System vs Regular Photocoagulation System: Changes in Macular Edema Post Treatment.
Study Type
Interventional

2. Study Status

Record Verification Date
November 2007
Overall Recruitment Status
Unknown status
Study Start Date
October 2007 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
February 2008 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Asociación para Evitar la Ceguera en México

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Laser photocoagulation has become the treatment of choice in PDR. Laser photocoagulation has become the treatment of choice in TMD. The aim is to destroy a substantial portion of the peripheral retina in order to reduce the angiogenic stimulus (decrease the difference between oxygen demand and the administration). Their effectiveness is determined by the extent of destruction of the retina (2.4).
Detailed Description
Introduction: The concept of retinal photocoagulation was introduced by Meyer-Schwickerath for treatment of diabetic retinopathy in the 50s (1, 6). The first successfully used laser was the arc xenon laser (polychromatic, inefficient, and hard to handle). Then the ruby and argon laser appeared (with mayor improvements in design and management). The modern era of photocoagulation as we know it began in the late 70s. With these available technologies, the focal photocoagulation, the panretinal photocoagulation and the grid photocoagulation were developed. Witch proved effective for the treatment of severe non-proliferative diabetic retinopathy, proliferative diabetic retinopathy in different multicenter studies (ETDRS, DRS) (1.6). Patients usually receive from 1200 to 1500 laser shots in 2 to 4 sessions lasting from 10 to 20 minutes, during 2 to 4 weeks. The procedure can be time consuming, tedious and painful. Until now little has changed in the overall design of lasers of 30 years ago. The differences are the introduction of fibre optics and air-based cooling systems. These innovations do not have any impact on the way in which the treatment or the success. Early efforts to improve photocoagulation included complex recognition systems and eye tracking to try to manage a fully automated process. That required a preview image of the retina. Attempts were also made to determine the appropriate dose of energy for getting the job done. The complexity of these systems prevented their clinical use (1). The PASCAL is a system of semiautomatic pattern laser, which allows much faster processing, accuracy and control of treatment by a doctor at all times. The difference with the regular laser systems is that PASCAL manages a dual frequency Nd: YAG that works at a wavelength of 532nm, which is capable of firing a single shot from up to 56 shots in pre patterns (1x1, 2 x2, 3x3, 4x4, 5x5). By using time exposures of between 10 and 20 ms, you can make multiple shots at the same time that a shot with conventional laser is done (100 ms). These short pulses allow energy laser focus better in the tissues, produces less pain, Reduce the heat delivered to the choroid, and less diffusion of heat with the subsequent less damage to surrounding tissues (1). The first study was published in the Retina 2006, by Blumenkanz, Palanker, Marcelino, et al. In which describe their use in rabbit's retinas. In which compared the effect of a number of pulses of different durations and powers. They applied exposition of 10, 20, 50 and 100 ms. The study found that at lower exposure time is required energy of 2 to 3 times more to produce the same effect, but the pulse had less energy. As they increased the exposure time, les power was needed, but the pulsed had also more energy. As the energy increased the shots was less homogeneous, less localized and changes in the final size (110-170micm) (1). ERG: It reflects the activity of the retina in "mass". In studies of the effect of photocoagulation on the activity of the retina, it have typically been used the amplitude of them a and b wave as criteria of tissue destruction. But there is no consistency among the various studies that have already reported variations of 10 to 95% in the amplitude (especially in wave b) due to the variability in the length of effective ablation of the retina. Others suggest that a wave to be smaller than the b, showing an injury in the primary layer of photoreceptors. Others say that the decline was equal in both waves. But something we all conclude is that the response in the ERG is reduced more than expected based in the coagulated area. But when it is higher, the fall in the ERG is more than what was expected (60% of destruction = 80% decrease of ERG). An average photocoagulation destroys about 40% of the retina approximately (5). The destruction of the peripheral retina decreases the ERG response, besides laser affect regions of adjacent tissue, causing deterioration in the transmission of signals from the photoreceptors in the proximal retina. What explains the previous reports of large decrease in amplitude on the basis of the area coagulated (2). The laser energy is absorbed by the RPE cells, and the adjacent layer of photoreceptors. What also produces external injury to the retina so you can also observe an increase in the implicit time (3). A few years ago changing arc xenon to argon marked a difference in the amount of burned retina and decrease in the implicit time and amplitudes of the waves (5). Macular Edema: Is recognized as a potential adverse effect of panretinal photocoagulation. Witch may transitory or permanent decrease the visual acuity of the patient. Approximately 60% of photocoagulated patients show an increase in the foveal thickness. Despite the fact that it has been said that a change of the self-distribution of blood flow is responsible for this increase in the thickness, today it is believed that these changes are due to post-laser inflammation. Despite that it is performed outside of the vascular arches; it is generally formed by those within. The inflammation factors, in addition to the direct effect that is exercised on intracellular unions have shown themselves capable of producing a change in the barrier mediated leukocytes. These factors are produced in the peripheral region to the photocoagulated area. The laser stimulates the production of adhesion molecules in the area around the shot and in the non photocoagulated area, which produces bearings and recruitment of leukocytes, secondary accumulation in the posterior pole and subsequent alteration of the hemato-retinal barrier (7).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non Proliferative Diabetic Retinopathy., Proliferative Diabetic Retinopathy.
Keywords
Pattern Scan Laser., Photocoagulation., Diabetic retinopathy treatment., Laser treatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
8 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
Panretinal photocoagulation with PASCAL system
Other Intervention Name(s)
Pattern Scan Laser system
Intervention Description
Use the PASCAL laser system to deliver a retina photocoagulation
Primary Outcome Measure Information:
Title
Retinal thickness after treatment
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
95 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients older than 25 years, with a diagnosis of severe NPDR or PRD. Good pupil mydriasis (minimum 5mm) With clear media Patients without previous laser treatment or treatment with antiangiogenic drug. Exclusion Criteria: Patients who do not accept informed consent. Patients with clinical macular Edema before treatment. Significant corneal opacity. Patients with other eye diseases that interfere with the studies required for the monitoring of patients. History of refractive surgery, glaucoma or ocular hypertension, intraocular inflammation, choroiditis multifocal, retinal detachment, optic neuropathy (4). Patients with tractional retinal detachment due to abundant fibrovascular tissue. Or important fibrovascular tissue that fold or detach the retina.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Raul Velez-Montoya, MD
Phone
525510841400
Ext
1171
Email
rvelezmx@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
Yoko Burgoa, Lic
Phone
525510841400
Ext
1172
Email
retinamex@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Raul Velez-Montoya, MD
Organizational Affiliation
Ascoiaciòn para Evitar la Ceguera en Mexico
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Hugo Quiroz-Mercado, MD
Organizational Affiliation
Asociaciòn para Evitar la Ceguera
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Virgilio Morales-Canton, MD
Organizational Affiliation
Asociaciòn para Evitar la Ceguera
Official's Role
Principal Investigator
Facility Information:
Facility Name
Asociaciòn para Evitar la Ceguera en Mèxico
City
Mexico
State/Province
DF
ZIP/Postal Code
04030
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yoko Burgoa, Lic
Phone
525510841400
Ext
1171
Email
retinamex@yahoo.com

12. IPD Sharing Statement

Citations:
PubMed Identifier
16508446
Citation
Blumenkranz MS, Yellachich D, Andersen DE, Wiltberger MW, Mordaunt D, Marcellino GR, Palanker D. Semiautomated patterned scanning laser for retinal photocoagulation. Retina. 2006 Mar;26(3):370-6. doi: 10.1097/00006982-200603000-00024. No abstract available.
Results Reference
background
PubMed Identifier
4039601
Citation
Perlman I, Gdal-On M, Miller B, Zonis S. Retinal function of the diabetic retina after argon laser photocoagulation assessed electroretinographically. Br J Ophthalmol. 1985 Apr;69(4):240-6. doi: 10.1136/bjo.69.4.240.
Results Reference
background
PubMed Identifier
11006264
Citation
Greenstein VC, Chen H, Hood DC, Holopigian K, Seiple W, Carr RE. Retinal function in diabetic macular edema after focal laser photocoagulation. Invest Ophthalmol Vis Sci. 2000 Oct;41(11):3655-64.
Results Reference
background
PubMed Identifier
15790915
Citation
Varano M, Parisi V, Tedeschi M, Sciamanna M, Gallinaro G, Capaldo N, Catalano S, Pascarella A. Macular function after PDT in myopic maculopathy: psychophysical and electrophysiological evaluation. Invest Ophthalmol Vis Sci. 2005 Apr;46(4):1453-62. doi: 10.1167/iovs.04-0903.
Results Reference
background
PubMed Identifier
6683566
Citation
Liang JC, Fishman GA, Huamonte FU, Anderson RJ. Comparative electroretinograms in argon laser and xenon arc panretinal photocoagulation. Br J Ophthalmol. 1983 Aug;67(8):520-5. doi: 10.1136/bjo.67.8.520.
Results Reference
background
PubMed Identifier
15976463
Citation
Rema M, Sujatha P, Pradeepa R. Visual outcomes of pan-retinal photocoagulation in diabetic retinopathy at one-year follow-up and associated risk factors. Indian J Ophthalmol. 2005 Jun;53(2):93-9. doi: 10.4103/0301-4738.16171.
Results Reference
background
PubMed Identifier
11923267
Citation
Nonaka A, Kiryu J, Tsujikawa A, Yamashiro K, Nishijima K, Kamizuru H, Ieki Y, Miyamoto K, Nishiwaki H, Honda Y, Ogura Y. Inflammatory response after scatter laser photocoagulation in nonphotocoagulated retina. Invest Ophthalmol Vis Sci. 2002 Apr;43(4):1204-9.
Results Reference
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Changes in Macular Thickness After Patterns Scan Laser

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