NCT00802269

Brief Summary

The used of reduced fluence parameters for panretinal photocoagulation decreases pain as perceived by the patient, compared to traditional parameters.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
25

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Mar 2008

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

March 1, 2008

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2008

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 3, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 4, 2008

Completed
Last Updated

May 30, 2024

Status Verified

May 1, 2024

Enrollment Period

8 months

First QC Date

December 3, 2008

Last Update Submit

May 29, 2024

Conditions

Proliferative Diabetic Retinopathy

Keywords

Proliferative diabetic retinopathyLaser photocoagulationPain

Outcome Measures

Primary Outcomes (1)

  • Pain (NRS-11 scale)

    Immediately post-treatment

Study Arms (2)

Reduced Fluence Parameters

EXPERIMENTAL

Eyes receiving retinal photocoagulation with reduced fluence parameters (time 20-50 msec, power 400-700 mW)

Procedure: Retinal laser photocoagulation

Traditional parameters

ACTIVE COMPARATOR

Eyes receiving retinal photocoagulation with traditional parameters (time 100-200 msec, power 200-400 mW)

Procedure: Retinal laser photocoagulation

Interventions

Retinal laser photocoagulationPROCEDURE

Retinal laser photocoagulation using a 532 nm laser

Also known as: Alcon Eyelite 532 (doubled frequency Nd:Yag)
Reduced Fluence ParametersTraditional parameters

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients 18 years or older, that signed informed consent
  • Proliferative diabetic retinopathy with indication for panretinal photocoagulation

You may not qualify if:

  • Previous retinal photocoagulation
  • Previous ocular surgical procedures
  • Ocular media opacities
  • History of trigeminal neuralgia
  • Chronic ocular pain
  • Depression under conductual or medical treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Asociacion para Evitar la Ceguera en Mexico

Mexico City, Mexico City, 04030, Mexico

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Oscar Alvarez-Verduzco, MD

    Asociación para Evitar la Ceguera en México

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

December 3, 2008

First Posted

December 4, 2008

Study Start

March 1, 2008

Primary Completion

November 1, 2008

Study Completion

November 1, 2008

Last Updated

May 30, 2024

Record last verified: 2024-05

Locations

ME(1)