NCT01033968

Brief Summary

The purpose of this study is to compare the pain perception at laser treatment of peripheral retinal degenerations with green and infrared wavelengths.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jan 2009

Status
completed

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

January 1, 2009

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

December 16, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 17, 2009

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2010

Completed
Last Updated

May 20, 2010

Status Verified

May 1, 2010

Enrollment Period

11 months

First QC Date

December 16, 2009

Last Update Submit

May 19, 2010

Conditions

Keywords

laserspain measurementphotocoagulationretina

Outcome Measures

Primary Outcomes (1)

  • Although the treatment of peripheral retinal degenerations with infrared laser to be well tolerated by the majority of the patients, it is more painful than with green wavelength.

Interventions

Each patient had one eye treated with infrared laser (diode, 810nm wavelength) and the other eye treated with green laser (frequency-doubled solid state laser, diode-pumped, with 532-nm wavelength

Eligibility Criteria

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

You may qualify if:

  • horseshoe tears and dialyses, besides operculated holes and lattice degeneration in symptomatic patients (photopsias) or with history of retinal disease

You may not qualify if:

  • severe liver disease, pregnancy, patients on regular analgesics, previous laser photocoagulation, and age less than 18 years old.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Lira RP, Nascimento MA, Arieta CE, de Carvalho KM, Silva VB. Pain perception at laser treatment of peripheral retinal degenerations with green and infrared wavelengths. Am J Ophthalmol. 2010 Nov;150(5):726-730.e1. doi: 10.1016/j.ajo.2010.05.027. Epub 2010 Aug 5.

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 16, 2009

First Posted

December 17, 2009

Study Start

January 1, 2009

Primary Completion

December 1, 2009

Study Completion

May 1, 2010

Last Updated

May 20, 2010

Record last verified: 2010-05