Cataract Surgery AnesthesiaPhase 4NCT07325227
Study of Remimazolam for Cataract Surgery
A Phase 4 study testing Arm 1 Cataract Surgery performed with remimazolam as sedative in people with Cataract Surgery Anesthesia, run by Fred E, Shapiro at 1 site in United States.
Trial summary
The goal of this clinical trial is to learn if the use of the sedative remimazolam improves the safety of patients having cataract surgery by decreasing the number of sedation-related complications during and after surgery, and shortening post-surgical cognitive recovery time. Read more about this study
- Who is it for?
- Ages 55 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Cataract Surgery Anesthesia
- What is being tested?
- Arm 1 Cataract Surgery performed with remimazolam as sedative
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Sep 2026to 1 Jun 2028
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subject is planning to have cataract surgery in both eyes
- The surgeon estimates that each cataract surgery are estimated to take less than 30 minutes
- Subject is aged 55 to 90 years old
- Surgeries will take place on the main campus of Mass Eye and Ear at 243 Charles St., Boston for at least the first year. In the future, surgeries may also occur at Mass Eye and Ear Longwood Surgical Ambulatory Care Center.
- Subject is able to understand the consent form and sign the consent
- ASA 1-3 (possible breakdown numbers of 5, 10, 10, 5)
Who cannot join
- Subject has a history of difficulty with sedation during procedures
- The surgeon estimates that one of the planned cataract surgeries is estimated to take longer than 30 minutes
- Subject uses concomitant home narcotic or anxiolytic
- Subject uses O2
- Subject has a history of cognitive decline
- A history of severe hepatic impairment
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Massachusetts Eye and Ear Infirmary
Boston, Massachusetts, 02114
Vikranth R. Chinthareddy, BA, 617-573-3380, vchinthareddy@meei.harvard.edu
Fred E. Shapiro, DO, FASA
About this study
Official title: Remimazolam for Sedation in Cataract Surgery, A Phase IV, On-label, Blinded Study
The goal of this clinical trial is to learn if the use of the sedative remimazolam improves the safety of patients having cataract surgery by decreasing the number of sedation-related complications during and after surgery, and shortening post-surgical cognitive recovery time.
Read the detailed description
Remimazolam (Byfavo) is a novel benzodiazepine approved by the U.S. Food and Drug Administration in July 2020 for sedation in patients undergoing procedures less than 30 minutes in duration. Remimazolam is a rapid onset/offset benzodiazepine, designed to be rapidly metabolized without active metabolites reduce the changes in cognitive function known to occur after even a brief exposure to a sedative. This study will use remimazolam on-label to sedate patients having cataract surgeries that take less than 30 minutes to perform. The investigator is studying the use of remimazolam in cataract surgery because the investigator think it will improve patient safety by shortening post-surgery cognitive recovery time and decreasing the number of sedation-related complications.
- Conditions
- Cataract Surgery Anesthesia
- Being tested
- Arm 1 Cataract Surgery performed with remimazolam as sedative, Arm 2 Cataract Surgery performed with standard of care sedative
- Keywords
- remimazolam, cataract surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arm 1 Cataract Surgery performed with remimazolam as sedativeDrug
Sedation will be remimazolam in one eye and the standard of care in the other eye.
Arm 2 Cataract Surgery performed with standard of care sedativeDrug
Standard of care sedative will be used during surgery.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 Cataract Surgery performed with remimazolam as sedative | Experimental | Subjects are serving as their own control. Subjects are scheduled for cataract surgery in both eyes. Sedation will be remimazolam in one eye and the standard of care in the other eye. The order of sedation will be randomly determined (50% of subjects will have remimazolam in the first eye surgery and 50% will have it in the second eye surgery.) Subjects will be blinded as to which sedation is provided at each surgery. Receives: Drug: Arm 1 Cataract Surgery performed with remimazolam as sedative |
| Arm 2 Cataract Surgery performed with a standard of care sedative | Placebo comparator | Subjects are serving as their own control. Subjects are scheduled for cataract surgery in both eyes. Sedation in this arm will be the standard of care. The order of sedation will be randomly determined (50% of subjects will have remimazolam in the first eye surgery and 50% will have it in the second eye surgery.) Subjects will be blinded as to which sedation is provided at each surgery. Receives: Drug: Arm 2 Cataract Surgery performed with standard of care sedative |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of sedation-related adverse events
The number of sedation-related adverse events from the time sedation is administered at the start of surgery through up to one week post-surgery.
Measured: Subjects consent to participate in study on day of surgery. AE data will be collected during surgery and through the following day when patient is contacted for follow-up. Adverse events will be documented up to one week after surgery should they occur
The severity of sedation-related adverse events
The severity (mild, moderate or severe) of sedation-related adverse events
Measured: Subjects consent to participate in study on day of surgery. AE data will be collected during surgery and through the following day when patient is contacted for follow-up. Adverse events will be documented up to one week after surgery should they occur
The duration of sedation-related adverse events
The duration, in minutes, hours, or days of sedation-related adverse events
Measured: Subjects consent to participate in study on day of surgery. AE data will be collected during surgery and through the following day when patient is contacted for follow-up. Adverse events will be documented up to one week after surgery should they occur
Time that subject remains in the post anesthesia care unit (PACU)
Length of time in minutes that subject remains in the post anesthesia care unit (PACU) until he or she meets criteria for discharge. We are recruiting subjects whose cataract surgery is deemed uncomplicated and anticipated to last no more than 30 minutes. This is required to use remimazolam on label. We anticipate that subjects would be in the PACU for less than sixty minutes, but that the use of remimazolam will lead to discharge in less than 30 minutes.
Measured: Minutes starting with arrival in PACU after surgery until subject meets criteria for discharge
Secondary outcomes (3)
Subjects' scores using the Aldrete Postanesthetic Recovery assessment
Subjects' scores on repeated assessments made by staff while they are in the PACU using the Aldrete Postanesthetic Recovery Score system.
The Aldrete Scoring System consists of 5 clinically relevant parameters reflecting physiological recovery from anesthesia: muscle activity, respiration, circulation, consciousness, and oxygenation. Each category is assigned a score of 0, 1, or 2, with a maximum possible total score of 10.
Measured: During the time subject is in the post anesthesia care unit (PACU)
Subjects' scores on the Richmond Agitation Sedation Scale (RASS)
Subjects' scores on repeated assessments made by staff while they are in the PACU using the Richmond Agitation Sedation Scale (RASS).
The Richmond Agitation Sedation Scale (RASS) was developed to assess the level of alertness and agitated behavior in patients who have received sedation. It is a 10-point scale ranging from -5 to +4. Levels -1 to -5 denote 5 levels of sedation and levels +1 to +4 describe increasing levels of agitation.
Measured: During the time subject is in the post anesthesia care unit (PACU)
Subjects' scores on patient satisfaction questionnaires
Subjects will be asked to complete a questionnaire regarding their satisfaction with the sedation they received and their post-surgical recovery
Measured: Questionnaire will be completed the day after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2026
- Study start15 Sep 2026 (estimated)
- Primary completion1 Jan 2028 (estimated)
- Study completion1 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cataract Surgery AnesthesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Subjects will be scheduled for cataract surgery in both eyes and they will serve as their own control, having sedation with the study drug remimazolam in one cataract surgery, and the standard of care sedation drug in the second surgery. To control for "second eye syndrome" a phenomenon where patients report increased discomfort, sensitivity, and / or slower healing at their second cataract surgery compared to the first, (even if no preoperative or intraoperative factor for that opinion could be identified) half of the subjects will have remimazolam as a sedative in their first cataract surgery and half will have it at the second surgery. Subjects will be blinded as to which sedation drug is used in each surgery.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fred E, Shapiro
- Sponsor type
- University, hospital or other
- Collaborators
- Eagle Pharmaceuticals, Inc., Massachusetts Eye and Ear Infirmary
- Responsible party
- Sponsor-investigator, Fred E, Shapiro, Massachusetts Eye and Ear Infirmary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07325227
- Sponsor's protocol ID
- 2025P002034
- Status last verified
- Jul 2026
- First submitted
- 9 Dec 2025
- Last updated
- 15 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study results will be published in a medical journal.
Publications
Alqudah A, Al-Dwairi R, Sharayah A, Al-Qudah NS, Almustafa YS, Al-Qudah A, Alharahsheh D, Al Awam RK, Al-Qudah H, Aleshawi A. Second Eye Syndrome: Patients' Perspectives Regarding First Eye versus Second Eye Phacoemulsification and Intraocular Lens Implantation Surgery. Patient Prefer Adherence. 2025 Jul 19;19:2081-2094. doi: 10.2147/PPA.S534166. eCollection 2025.
PubMed 40704218
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Remimazolam for Sedation in Cataract Surgery, A Phase IV, On-label, Blinded Study
- ClinicalTrials.gov ID
- NCT07325227
- Acronym / sponsor ID
- 2025P002034
- Conditions
- Cataract Surgery Anesthesia
- Keywords
- remimazolam, cataract surgery
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Fred E, ShapiroUniversity, hospital or other
- Collaborators
- Eagle Pharmaceuticals, Inc., Massachusetts Eye and Ear Infirmary
- Study start
- 15 Sep 2026 (estimated)
- Primary completion
- 1 Jan 2028 (estimated)
- Study completion
- 1 Jun 2028 (estimated)
- First posted
- 8 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to learn if the use of the sedative remimazolam improves the safety of patients having cataract surgery by decreasing the number of sedation-related complications during and after surgery, and shortening post-surgical cognitive recovery time.
Detailed description
Remimazolam (Byfavo) is a novel benzodiazepine approved by the U.S. Food and Drug Administration in July 2020 for sedation in patients undergoing procedures less than 30 minutes in duration. Remimazolam is a rapid onset/offset benzodiazepine, designed to be rapidly metabolized without active metabolites reduce the changes in cognitive function known to occur after even a brief exposure to a sedative. This study will use remimazolam on-label to sedate patients having cataract surgeries that take less than 30 minutes to perform. The investigator is studying the use of remimazolam in cataract surgery because the investigator think it will improve patient safety by shortening post-surgery cognitive recovery time and decreasing the number of sedation-related complications.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Subjects will be scheduled for cataract surgery in both eyes and they will serve as their own control, having sedation with the study drug remimazolam in one cataract surgery, and the standard of care sedation drug in the second surgery. To control for "second eye syndrome" a phenomenon where patients report increased discomfort, sensitivity, and / or slower healing at their second cataract surgery compared to the first, (even if no preoperative or intraoperative factor for that opinion could be identified) half of the subjects will have remimazolam as a sedative in their first cataract surgery and half will have it at the second surgery. Subjects will be blinded as to which sedation drug is used in each surgery.
| Arm | Type | Receives |
|---|---|---|
| Arm 1 Cataract Surgery performed with remimazolam as sedative | Experimental | Drug: Arm 1 Cataract Surgery performed with remimazolam as sedativeSubjects are serving as their own control. Subjects are scheduled for cataract surgery in both eyes. Sedation will be remimazolam in one eye and the standard of care in the other eye. The order of sedation will be randomly determined (50% of subjects will have remimazolam in the first eye surgery and 50% will have it in the second eye surgery.) Subjects will be blinded as to which sedation is provided at each surgery. |
| Arm 2 Cataract Surgery performed with a standard of care sedative | Placebo comparator | Drug: Arm 2 Cataract Surgery performed with standard of care sedativeSubjects are serving as their own control. Subjects are scheduled for cataract surgery in both eyes. Sedation in this arm will be the standard of care. The order of sedation will be randomly determined (50% of subjects will have remimazolam in the first eye surgery and 50% will have it in the second eye surgery.) Subjects will be blinded as to which sedation is provided at each surgery. |
Who may qualify
- Ages
- 55 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Subject is planning to have cataract surgery in both eyes
- The surgeon estimates that each cataract surgery are estimated to take less than 30 minutes
- Subject is aged 55 to 90 years old
- Surgeries will take place on the main campus of Mass Eye and Ear at 243 Charles St., Boston for at least the first year. In the future, surgeries may also occur at Mass Eye and Ear Longwood Surgical Ambulatory Care Center.
- Subject is able to understand the consent form and sign the consent
Key exclusion criteria (6 listed)
- Subject has a history of difficulty with sedation during procedures
- The surgeon estimates that one of the planned cataract surgeries is estimated to take longer than 30 minutes
- Subject uses concomitant home narcotic or anxiolytic
- Subject uses O2
- Subject has a history of cognitive decline
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Arm 1 Cataract Surgery performed with remimazolam as sedativeSedation will be remimazolam in one eye and the standard of care in the other eye. | Drug | Arm 1 Cataract Surgery performed with remimazolam as sedative |
| Arm 2 Cataract Surgery performed with standard of care sedativeStandard of care sedative will be used during surgery. | Drug | Arm 2 Cataract Surgery performed with a standard of care sedative |
Primary outcome
The number of sedation-related adverse events
Time frame: Subjects consent to participate in study on day of surgery. AE data will be collected during surgery and through the following day when patient is contacted for follow-up. Adverse events will be documented up to one week after surgery should they occur
The number of sedation-related adverse events from the time sedation is administered at the start of surgery through up to one week post-surgery.
The severity of sedation-related adverse events
Time frame: Subjects consent to participate in study on day of surgery. AE data will be collected during surgery and through the following day when patient is contacted for follow-up. Adverse events will be documented up to one week after surgery should they occur
The severity (mild, moderate or severe) of sedation-related adverse events
The duration of sedation-related adverse events
Time frame: Subjects consent to participate in study on day of surgery. AE data will be collected during surgery and through the following day when patient is contacted for follow-up. Adverse events will be documented up to one week after surgery should they occur
The duration, in minutes, hours, or days of sedation-related adverse events
Time that subject remains in the post anesthesia care unit (PACU)
Time frame: Minutes starting with arrival in PACU after surgery until subject meets criteria for discharge
Length of time in minutes that subject remains in the post anesthesia care unit (PACU) until he or she meets criteria for discharge. We are recruiting subjects whose cataract surgery is deemed uncomplicated and anticipated to last no more than 30 minutes. This is required to use remimazolam on label. We anticipate that subjects would be in the PACU for less than sixty minutes, but that the use of remimazolam will lead to discharge in less than 30 minutes.
3 secondary outcomes
Subjects' scores using the Aldrete Postanesthetic Recovery assessment
Time frame: During the time subject is in the post anesthesia care unit (PACU)
Subjects' scores on the Richmond Agitation Sedation Scale (RASS)
Time frame: During the time subject is in the post anesthesia care unit (PACU)
Subjects' scores on patient satisfaction questionnaires
Time frame: Questionnaire will be completed the day after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2026.
- Background: PubMed 40704218Alqudah A, Al-Dwairi R, Sharayah A, Al-Qudah NS, Almustafa YS, Al-Qudah A, Alharahsheh D, Al Awam RK, Al-Qudah H, Aleshawi A. Second Eye Syndrome: Patients' Perspectives Regarding First Eye versus Second Eye Phacoemulsification and Intraocular Lens Implantation Surgery. Patient Prefer Adherence. 2025 Jul 19;19:2081-2094. doi: 10.2147/PPA.S534166. eCollection 2025.
- Individual participant dataSharing planned: Yes. Study results will be published in a medical journal.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Arm 1 Cataract Surgery performed with remimazolam as sedative in people with Cataract Surgery Anesthesia, run by Fred E, Shapiro at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 15 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Vikranth R. Chinthareddy, BA (617-573-3380, vchinthareddy@meei.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The number of sedation-related adverse events (time frame: Subjects consent to participate in study on day of surgery. AE data will be collected during surgery and through the following day when patient is contacted for follow-up. Adverse events will be documented up to one week after surgery should they occur). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07325227, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2026.