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Laser Therapy

Micropulse Laser Treatment for Diabetic Macular Edema (PULSE Trial)

N/A

Waitlist Available

Led By Glenn Yiu, MD, PhD

Research Sponsored by University of California, Davis

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 month

Awards & highlights

PULSE Trial Summary

This trial will help researchers understand if early intervention with micropulse laser treatment can improve or stabilize vision in people with diabetes who have good visual acuity.

Eligible Conditions

Diabetic Macular Edema

PULSE Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 month

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 month

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 month for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Percentage of subjects with vision loss to 20/40 or worse

Secondary outcome measures

Average change in Visual Acuity

PULSE Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: Micropulse Laser TreatmentActive Control1 Intervention

Subjects assigned to the micropulse laser arm of the trial will undergo the following procedures: Confirmation of the subject's identity and eye to be treated Subject's eye will be dilated Subject will be positioned at the slit lamp for treatment Application of subthreshold micropulse laser using the Iridex IQ577 laser unit. (intermittent pulsed energy) in a 7 X 7 grid pattern surrounding the fovea.

Group II: Sham TreatmentPlacebo Group1 Intervention

Subjects assigned to the sham arm of the trial will undergo the following procedures: Confirmation of the subject's identity and eye to be treated Subject's eye will be dilated Subject will be positioned at the slit lamp for treatment No Actual laser treatment will occur

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Who is running the clinical trial?

University of California, DavisLead Sponsor

910 Previous Clinical Trials

4,706,964 Total Patients Enrolled

IRIDEX CorporationUNKNOWN

2 Previous Clinical Trials

256 Total Patients Enrolled

Glenn Yiu, MD, PhDPrincipal InvestigatorUniversity of California, Davis

1 Previous Clinical Trials

60 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many individuals are being accepted into this clinical trial?

"Indeed, the clinical trial registry reveals that this research study is presently enrolling participants. It was originally posted on April 20th 2018 and most recently updated on January 25th 2022. At present, 30 volunteers are being sought from a single medical site."

Answered by AI

Are there any vacant spaces for participants in this research endeavor?

"Affirmative. According to clinicaltrials.gov, this medical research is looking for participants and was first launched on April 20th 2018. The data has been updated as recently as January 25th 2022 with 30 individuals being sought out from a single site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Micropulse for Suppression of Diabetic Macular Edema

2018. "Micropulse for Suppression of Diabetic Macular Edema". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03519581.