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Could a melt tablet replace IV sedation for eye surgery?

NCT ID NCT04725747

Symptom relief Sponsor: Vance Thompson Vision Source: ClinicalTrials.gov ↗

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looked at whether a melt tablet containing midazolam and ketamine works as well as IV sedation for keeping people calm and pain-free during cataract surgery. Over 1,100 adults aged 55-80 took part. Researchers measured sedation levels, pain scores, and whether extra pain medicine was needed.

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Study facts

What this study's own registry entry says, in plain language.

Participants

1,111 people

The number who actually took part.

Started

Jan 2021

Finished

Jun 2021

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Subjects requiring cataract removal

Ages

55 to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Subjects must be male or female, and between the ages of 55-80 years old. 2. Subjects willing and able to sign the informed consent and capable of committing to the duration of the study. 3. Subjects undergoing uncomplicated stand-alone cataract surgery without planned use of Omidria or intra-operative lidocaine. 4. Subjects that are willing to have an IV placed prior to intraocular surgery 5. Subjects undergoing first eye cataract surgery 6. Subjects that in the opinion of the investigator can tolerate 1 dose of MK 3/50 Melt. Exclusion Criteria: 1. Subjects who have undergone sedation in the past 90 days. 2. Women who are pregnant or lactating at the time of the study. 3. Subjects who do not wish to or cannot comply with study procedures. 4. Subject with any cognitive impairment (i.e: Alzheimer's, dementia, etc.) that in the opinion of the investigator may confound the study results. 5. Subjects with history of substance abuse. 6. Subjects that are currently taking a prescription pain medication. 7. 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. 8. Subjects that are not willing to abstain from NSAID or steroid eye drops prior to surgery. 9. Subjects with planned use of femtosecond laser, zepto, iris hooks or a malyugin ring during cataract surgery. 10. Subjects with chronic pain rated moderate to severe within the past week. 11. Subjects that have a psychiatric disorder that is currently uncontrolled. 12. Subjects scheduled for same day bilateral or second eye cataract surgery.

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Conditions

The condition(s) this trial relates to.

cataract

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Vital signs

Contacts and locations

Locations

  • Vance Thompson Vision

    Sioux Falls, South Dakota, 57108, United States

  • Vance Thompson Vision Clinic

    Sioux Falls, South Dakota, 57108, United States

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