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Procedure

Immediate vs. Deferred Surgery for Macular Pucker (Protocol AM Trial)

N/A
Recruiting
Research Sponsored by Jaeb Center for Health Research
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
ERM is not secondary to another condition
Epiretinal membrane involving or altering the central 3 mm of the macula on OCT
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to 36 months
Awards & highlights

Protocol AM Trial Summary

This trial is examining the best time to do surgery for people with an eye condition called an epiretinal membrane, to see if earlier surgery leads to better outcomes than waiting until vision gets worse.

Who is the study for?
This trial is for people with a condition called Macular Pucker, who have vision between 20/25 and 20/40. They should experience visual loss or distortion due to an epiretinal membrane (ERM) affecting the central part of the retina. Surgery shouldn't be urgently needed, and they mustn't have other health issues that make surgery risky.Check my eligibility
What is being tested?
The study compares immediate vs. deferred vitrectomy surgery in patients with symptomatic ERM to determine which timing results in better vision outcomes. It also aims to identify factors predicting success when surgery is performed and progression if it's delayed.See study design
What are the potential side effects?
While specific side effects are not listed here, vitrectomy procedures can generally lead to complications like infection, bleeding inside the eye, retinal detachment, cataracts, or changes in eye pressure.

Protocol AM Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My eye condition is not caused by another health issue.
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I have a membrane affecting the central part of my retina.
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I am 45 years old or older.

Protocol AM Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to 36 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 36 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Mean change in visual acuity letter score from baseline to 36 months

Protocol AM Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Deferred VitrectomyExperimental Treatment1 Intervention
Group II: Immediate VitrectomyActive Control1 Intervention

Find a Location

Who is running the clinical trial?

Jaeb Center for Health ResearchLead Sponsor
152 Previous Clinical Trials
34,334 Total Patients Enrolled
National Institutes of Health (NIH)NIH
2,684 Previous Clinical Trials
6,930,498 Total Patients Enrolled
National Eye Institute (NEI)NIH
546 Previous Clinical Trials
1,401,594 Total Patients Enrolled

Media Library

Deferred Vitrectomy (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT05145491 — N/A
Macular Pucker Research Study Groups: Immediate Vitrectomy, Deferred Vitrectomy
Macular Pucker Clinical Trial 2023: Deferred Vitrectomy Highlights & Side Effects. Trial Name: NCT05145491 — N/A
Deferred Vitrectomy (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05145491 — N/A

Frequently Asked Questions

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

How many healthcare providers are administering this trial?

"This study has been launched in 24 locations including Spokane Eye Clinical Research, PLLC (Spokane), Valley Eye Physicians and Surgeons (Ayer), Southeast Retina Center, PC (Augusta)."

Answered by AI

How many participants are you looking to recruit for this research endeavor?

"Affirmative, clinicaltrials.gov exhibits that this research is actively recruiting participants. The trial was initially advertised on February 22nd 2022 and has since been updated as recently as October 13th 2022. 400 individuals are being sought out from 24 different sites for the study."

Answered by AI

Is this experiment recruiting participants presently?

"Affirmative. Clinicaltrials.gov provides evidence that this study is currently recruiting with a posting date of February 22nd 2022 and an update on October 13th 2022. A total of 400 individuals must be enlisted from 24 distinct sites."

Answered by AI

Who else is applying?

What state do they live in?
California
Ohio
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Did not meet criteria
What site did they apply to?
Regents of the University of California, Davis, DBA University of California, Davis
How many prior treatments have patients received?
0
~228 spots leftby Dec 2026