CompletedNot Applicable

Exploring Sedation Types During Cataract Surgery

United States1,111 participantsStarted 2021-01-25

Plain-language summary

This study is designed to explore the sedative and analgesic effectiveness of the Midazolam/Ketamine melt compared to IV sedation in subjects undergoing intraocular surgery.

Who can participate

Age range55 Years – 80 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Subjects must be male or female, and between the ages of 55-80 years old.
✓. Subjects willing and able to sign the informed consent and capable of committing to the duration of the study.
✓. Subjects undergoing uncomplicated stand-alone cataract surgery without planned use of Omidria or intra-operative lidocaine.
✓. Subjects that are willing to have an IV placed prior to intraocular surgery
✓. Subjects undergoing first eye cataract surgery
✓. Subjects that in the opinion of the investigator can tolerate 1 dose of MK 3/50 Melt.

Exclusion criteria

✕. Subjects who have undergone sedation in the past 90 days.
✕. Women who are pregnant or lactating at the time of the study.
✕. Subjects who do not wish to or cannot comply with study procedures.
✕. Subject with any cognitive impairment (i.e: Alzheimer's, dementia, etc.) that in the opinion of the investigator may confound the study results.
✕. Subjects with history of substance abuse.
✕. Subjects that are currently taking a prescription pain medication.
✕. Subjects that are not willing to abstain from all over-the-counter pain medication with the exception of 500-1000mg acetaminophen for 24 hours prior to surgery.
✕. Subjects that are not willing to abstain from NSAID or steroid eye drops prior to surgery.

What they're measuring

Level of Sedation

Timeframe: Duration of surgery

Level of Pain

Timeframe: Duration of surgery

Need for Rescue Medication

Timeframe: Duration of surgery

Trial details

NCT IDNCT04725747

SponsorVance Thompson Vision

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2021-05-30

View on ClinicalTrials.gov More Vital Signs trials

Who can participate

Age range55 Years – 80 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Subjects must be male or female, and between the ages of 55-80 years old.
✓. Subjects willing and able to sign the informed consent and capable of committing to the duration of the study.
✓. Subjects undergoing uncomplicated stand-alone cataract surgery without planned use of Omidria or intra-operative lidocaine.
✓. Subjects that are willing to have an IV placed prior to intraocular surgery
✓. Subjects undergoing first eye cataract surgery
✓. Subjects that in the opinion of the investigator can tolerate 1 dose of MK 3/50 Melt.

Exclusion criteria

✕. Subjects who have undergone sedation in the past 90 days.
✕. Women who are pregnant or lactating at the time of the study.
✕. Subjects who do not wish to or cannot comply with study procedures.
✕. Subject with any cognitive impairment (i.e: Alzheimer's, dementia, etc.) that in the opinion of the investigator may confound the study results.
✕. Subjects with history of substance abuse.
✕. Subjects that are currently taking a prescription pain medication.
✕. Subjects that are not willing to abstain from all over-the-counter pain medication with the exception of 500-1000mg acetaminophen for 24 hours prior to surgery.
✕. Subjects that are not willing to abstain from NSAID or steroid eye drops prior to surgery.