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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

Awards & highlights

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, an average of 1 year

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.

0 / 18Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Institutes of Health (NIH)NIH

2,765 Previous Clinical Trials

8,133,501 Total Patients Enrolled

National Institute on Aging (NIA)NIH

1,733 Previous Clinical Trials

28,054,993 Total Patients Enrolled

University of California, San FranciscoLead Sponsor

2,551 Previous Clinical Trials

15,257,876 Total Patients Enrolled

~7 spots leftby Sep 2025

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