NCT00563043

Brief Summary

Laser photocoagulation has become the treatment of choice in PDR. Laser photocoagulation has become the treatment of choice in PDR. 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).

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Oct 2007

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2007

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2007

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 22, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 26, 2007

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2008

Completed
Last Updated

May 30, 2024

Status Verified

May 1, 2024

Enrollment Period

Same day

First QC Date

November 22, 2007

Last Update Submit

May 29, 2024

Conditions

Non Proliferative Diabetic RetinopathyProliferative Diabetic Retinopathy

Keywords

Pattern Scan Laser.Photocoagulation.Diabetic retinopathy treatment.Laser treatment.Electroretinogram.a wave.b wave.Implicit time.

Outcome Measures

Primary Outcomes (3)

  • Changes in a wave amplitude

    12 weeks

  • changes in b wave amplitude

    12 weeks

  • changes in ERG implicit time

    12 weeks

Interventions

PASCAL laser treatmentPROCEDURE

Patterns Scan Laser treatment in patients with PDR.

Eligibility Criteria

Age25 Years - 95 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Asociaciòn para Evitar la Ceguera en Mèxico

Mèxico, Mexico City, 04030, Mexico

Location

Related Publications (7)

  • 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.

    PMID: 16508446BACKGROUND

  • 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.

    PMID: 4039601BACKGROUND

  • 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.

    PMID: 11006264BACKGROUND

  • 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.

    PMID: 15790915BACKGROUND

  • 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.

    PMID: 6683566BACKGROUND

  • 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.

    PMID: 15976463BACKGROUND

  • 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.

    PMID: 11923267BACKGROUND

Study Officials

  • Raul Velez-Montoya, MD

    Asociaciòn para Evitar la Ceguera en Mèxico

    PRINCIPAL INVESTIGATOR

  • Hugo Quiroz-Mercado, MD

    Asociaciòn para Evitar la Ceguera en Mèxico

    PRINCIPAL INVESTIGATOR

  • Virgilio Morales-Canton, MD

    Asociaciòn para Evitar la Ceguera en Mèxico

    PRINCIPAL INVESTIGATOR

  • Juan Manuel Jimenez-Sierra, MD

    Asociaciòn para Evitar la Ceguera en Mèxico

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 22, 2007

First Posted

November 26, 2007

Study Start

October 1, 2007

Primary Completion

October 1, 2007

Study Completion

February 1, 2008

Last Updated

May 30, 2024

Record last verified: 2024-05

Locations

ME(1)