A Randomized, Double-Masked, Controlled, Single Site Investigator Initiated, Exploratory Study of the Midazolam/Ketamine Melt vs Ketamine Melt Alone vs Midazolam Melt Alone in Subjects Undergoing Intraocular Surgery.

• Status: Not yet recruiting
• Trial end date: 2021-06-30
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Vance Thompson Vision
• Treatments: Ketamine; Midazolam

Criteria

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.