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Sedation Methods for Cataract Surgery (CaTNAPS-1 Trial)

N/A
Recruiting
Led By Catherine L Chen, M.D.
Research Sponsored by University of California, San Francisco
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
≥ 65 years old
Able to climb one flight of stairs without stopping to rest
Must not have
Untreated chest pain or angina
History of prior cataract surgery
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 1 year

Summary

"This trial aims to compare two sedation methods for cataract surgery to see which one patients prefer and which leads to better recovery and surgical results. Participants will fill out surveys about their experience and outcomes

Who is the study for?
This trial is for individuals undergoing cataract surgery, specifically those with senile cataracts. Participants should be interested in contributing to research on sedation methods and willing to complete surveys about their experience.
What is being tested?
The study compares two sedation approaches during cataract surgery: one group receives a placebo while the other gets oral sedation. The focus is on patient satisfaction, recovery quality, and surgical outcomes.
What are the potential side effects?
Possible side effects may include typical reactions to anesthesia such as drowsiness, mild disorientation or confusion post-surgery. Oral sedation can also cause dry mouth, low blood pressure or nausea.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 65 years old or older.
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I can climb stairs without needing to rest.
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I am planning to have cataract surgery within 6 months.
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I have been newly diagnosed with cataracts.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have chest pain or angina that hasn't been treated.
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I have had cataract surgery in the past.
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I need oxygen at home, either all the time or when I move around.
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I am on dialysis for end-stage kidney disease.
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My BMI is over 35.
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I was admitted to the hospital within the last 30 days.
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I do not have severe heart valve disease.
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I need general anesthesia for my cataract surgery due to its complexity.
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I have had a stroke, mini-stroke, or seizures.
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I cannot lay flat without feeling discomfort or pain.
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I regularly use benzodiazepines for severe anxiety.
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I have a heart condition that required the implantation of a device like a pacemaker.
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I have a movement disorder like Parkinson's Disease.
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I am having cataract surgery along with another eye procedure.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Patient Satisfaction as assessed by the Iowa Satisfaction With Anesthesia Scale (ISAS)
Secondary study objectives
Incidence of sedation-related complications after surgery
Proportion of patients completing all study surveys after cataract surgery
Proportion of patients meeting eligibility criteria
+4 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: InterventionExperimental Treatment1 Intervention
Oral sedation will be administered to patients prior to the procedure.
Group II: PlaceboPlacebo Group1 Intervention
An oral placebo pill will be administered to patients prior to the procedure.

Find a Location

Who is running the clinical trial?

National Institutes of Health (NIH)NIH
2,817 Previous Clinical Trials
8,161,749 Total Patients Enrolled
National Institute on Aging (NIA)NIH
1,789 Previous Clinical Trials
28,188,322 Total Patients Enrolled
University of California, San FranciscoLead Sponsor
2,587 Previous Clinical Trials
14,901,166 Total Patients Enrolled
~3 spots leftby Feb 2025
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