AzTrials
AzTrials

Cataract and IOL SurgeryNCT07223866

The Impact of Physiologic Cataract Surgery on Patient Comfort and Medication Usage

A study testing High IOP Setting and Low IOP Setting in people with Cataract and IOL Surgery and Cataract Surgery Anesthesia, run by Matthew Rauen at 1 site in United States.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

The study will pertain to investigating the impact of high vs low IOP on the intraoperative experience and comfort for the patient and surgeon. Our hypothesis is that operating at a more physiological IOP using Unity VCS/CS and Centurion with Active Sentry at a higher, or more traditional IOP will result in… Read more about this study

Who is it for?
Ages 60 years and older
What is being tested?
High IOP Setting and Low IOP Setting
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
85 participants
Where
1 siteUnited States
Study dates
1 Nov 2025to 1 Jan 2027
Phase
Interventional
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 60 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Visually significant cataract 2-3+ undergoing uncomplicated cataract surgery with similar cataract grade in both eyes
  • Unremarkable ocular health but inclusive of early AMD

Who cannot join

  • H/o ocular surgery including corneal refractive surgery
  • Compromised zonular integrity or stability
  • Uncontrolled diabetes and diabetic retinopathy
  • Small pupils
  • H/o systemic inflammatory disease/uveitis
  • H/o chronic pain medications (including narcotics) and benzodiazepine usage
  • Abnormal liver or renal function

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Robyn Kohler, RN contact

515-223-8685

rkohler@wolfeclinic.com

United States1 site

  • Wolfe Eye Clinic and Wolfe Surgery Center

    West Des Moines, Iowa, 50266

    Robyn Kohler, RN, 515-223-8685, rkohler@wolfeclinic.com

Other trials in United States

About this study

The study will pertain to investigating the impact of high vs low IOP on the intraoperative experience and comfort for the patient and surgeon. Our hypothesis is that operating at a more physiological IOP using Unity VCS/CS and Centurion with Active Sentry at a higher, or more traditional IOP will result in significantly less discomfort/pain as assessed by the decreased need for rescue medication and lower VAS scores.

Read the detailed description

Objective/ Unmet Medical Need:

To investigate the impact of Unity VCS/CS with Intelligent Fluidics at a low IOP setting and Centurion with Active Sentry at a traditionally high IOP setting on the intraoperative experience for the patient and surgeon. Limited research on phacoemulsification at near physiological IOP and its impact on patient discomfort/pain using the Unity VCS/CS system.

Design:

Prospective, single-surgeon, eyes undergoing phacoemulsification will be randomized to high (IOP 65mmHg) or low (IOP 25mmHg) IOP, contralateral eye will receive other treatment.

STUDY HYPOTHESIS Unity VCS/CS with Intelligent Fluidics during cataract surgery will result in significantly less discomfort/pain as assessed by the decreased need for rescue medication and lower VAS scores.

Being tested
High IOP Setting, Low IOP Setting
Medical subject headings
Cataract

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • High IOP SettingDevice

    Prospective, single-surgeon, eyes undergoing phacoemulsification will be randomized to low (IOP 25mmHg) or high (IOP 65mmHg) IOP, contralateral eye will receive other treatment

  • Low IOP SettingDevice

    Prospective, single-surgeon, eyes undergoing phacoemulsification will be randomized to low (IOP 25mmHg) or high (IOP 65mmHg) IOP, contralateral eye will receive other treatment

Study groups in NCT07223866
Study groupRoleWhat they receive
Centurion with Active Sentry at a traditionally high IOP settingActive comparatorCenturion with Active Sentry at a traditionally high IOP setting, Eyes in this arm will maintain an Intraocular Pressure (IOP) of 65 millimeters of mercury (mmHg) throughout the cataract surgery.
Receives: Device: High IOP Setting
Unity VCS/CS with Intelligent Fluidics at a low IOP settingActive comparatorUnity VCS/CS with Intelligent Fluidics at a low IOP setting. Eyes in this arm will maintain an Intraocular Pressure (IOP) of 25 millimeters of mercury (mmHg) throughout the cataract surgery.
Receives: Device: Low IOP Setting

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Rescue Medication

    Percent of pts in each group requiring rescue medication for breakthrough discomfort/pain

    Measured: During cataract surgery

Secondary outcomes (7)

  1. VAS Pain Score

    Discomfort/pain score at phaco, I/A, visco removal. VAS score : 0 - no pain, 10 - unbearable pain

    Measured: During Phaco, I/A, and Visco Removal

  2. Surgeon Intraoperative Experience

    1- Poor: fluctuating chamber (reverse pupillary block or surge) and reduced efficiency (nucleus \& cortex removal)

    • 2- Good: >75% chamber stability and adequate efficiency
    • 3- Excellent: Minimal to no fluctuating chamber and excellent efficiency

    Measured: During cataract surgery

  3. Cost Analysis

    Cost-analysis on intraoperative medications utilized in high vs low IOP groups

    Measured: During cataract surgery

  4. Breakthrough pain and discomfort High Axial Length

    VAS Pain score on subjects with axial length of >24.5mm VAS score : 0 - no pain, 10 - unbearable pain If patients experienced breakthrough pain during surgery, additional topical anesthetic, intracameral lidocaine, and/or opioid will be used per surgeon discretion and stage of surgery recorded.

    Measured: During cataract surgery

  5. 1 day Post Op Patient Survey

    • on experience (Iowa Satisfaction with Anesthesia Scale (ISAS)
    • on patient preference - What eye was more comfortable? (R/L)
    • surgical experience did you enjoy more? (R/L)
    • x% of eyes would undergo the same procedure again
    • x% of eyes would recommend the procedure to family and friends

    Measured: 1 day post op cataract surgery, each eye

  6. Anesthesiologist Review Blood Pressure

    Physiological responses recorded: Anesthesiologist will monitor patients per standard of care but will record additional Blood Pressure values at the start of the case (room entry), 4 minutes after versed is administered, during phacoemulsification, and during viscoelastic removal.

    Measured: During cataract surgery

  7. Anesthesiologist Review Pulse Rate

    Physiological responses recorded: Anesthesiologist will monitor patients per standard of care but will record additional Pulse Rate values at the start of the case (room entry), 4 minutes after versed is administered, during phacoemulsification, and during viscoelastic removal.

    Measured: During cataract surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Nov 2025
  2. Study start1 Nov 2025 (estimated)
  3. Primary completion1 Nov 2026 (estimated)
  4. Study completion1 Jan 2027 (estimated)

Resources

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 N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Model description
Study treatment \& Methods: * Sequential cataract surgery with similar cataract grade 2-3+ based on LOCS III grading bilaterally; 2nd eye to be completed within 2-3 weeks of first eye * Randomize first eye to low vs high IOP, contralateral eye receives opposite IOP * Patient education on VAS with standard script * Standard pre-op drops: 2 drops of cyclopentolate 1%, tropicamide 1%, flurbiprofen sodium (Ocufen 0.03%), phenylephrine hydrochloride 2.5%, and 3 drops of marcaine 0.05% * After draping, patients receive OcuCoat on cornea and 3 drops of lidocaine, 1mg of Versed (midazolam for anxiety with no analgesic effects) * If patients experienced breakthrough pain during surgery, additional topical anesthetic, intracameral lidocaine, and/or opioid will be used per surgeon discretion and stage recorded * Physiological responses recorded: Anesthesiologist will monitor patients per standard of care but will record additional BP/HR values at the start of the case (room entry), 4 minutes
Masking
Single blind
Who is masked
Care provider
Enrolment
85 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07223866
Sponsor's protocol ID
IIT #98621123
Status last verified
Nov 2025
First submitted
20 Oct 2025
Last updated
10 Nov 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
Yes: We will share informed consent and study protocol.

Publications

  • Liu YC, Setiawan M, Ang M, Yam GHF, Mehta JS. Changes in aqueous oxidative stress, prostaglandins, and cytokines: Comparisons of low-energy femtosecond laser-assisted cataract surgery versus conventional phacoemulsification. J Cataract Refract Surg. 2019 Feb;45(2):196-203. doi: 10.1016/j.jcrs.2018.09.022. Epub 2018 Dec 6.

    PubMed 30528516

  • Scarfone HA, Rodriquez EC. Evaluation of Early Changes of the Anterior Vitreous Interface after Cataract Surgery, using Low-Pressure Settings Determined by OCT. ASCRS 2023 May 6, San Diego Convention Center. https://ascrs.confex.com/ascrs/23am/meetingapp.cgi/Paper/88373

  • Donnenfeld ED, Mychajlyszyn D, Mychajlyszyn A, Stein R. Pain control and reduction of opioid use associated with intracameral phenylephrine1.0%-ketorolac 0.3% administered during cataract surgery. J Cataract Refract Surg. 2022 Jul 1;48(7):759-764. doi: 10.1097/j.jcrs.0000000000000855. Epub 2021 Oct 29.

    PubMed 34860481

  • Reddy AJ, Dang A, Dao AA, Arakji G, Cherian J, Brahmbhatt H. A Substantive Narrative Review on the Usage of Lidocaine in Cataract Surgery. Cureus. 2021 Oct 30;13(10):e19138. doi: 10.7759/cureus.19138. eCollection 2021 Oct.

    PubMed 34737914

  • Crandall AS, Zabriskie NA, Patel BC, Burns TA, Mamalis N, Malmquist-Carter LA, Yee R. A comparison of patient comfort during cataract surgery with topical anesthesia versus topical anesthesia and intracameral lidocaine. Ophthalmology. 1999 Jan;106(1):60-6. doi: 10.1016/S0161-6420(99)90007-6.

    PubMed 9917782

  • Gills JP, Cherchio M, Raanan MG. Unpreserved lidocaine to control discomfort during cataract surgery using topical anesthesia. J Cataract Refract Surg. 1997 May;23(4):545-50. doi: 10.1016/s0886-3350(97)80211-8.

    PubMed 9209989

Questions about this trial

What is this clinical trial studying?

A study testing High IOP Setting and Low IOP Setting in people with Cataract and IOL Surgery and Cataract Surgery Anesthesia, run by Matthew Rauen 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 2 inclusion and 7 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 10 Nov 2025. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

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 Robyn Kohler, RN (515-223-8685, rkohler@wolfeclinic.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Rescue Medication (time frame: During cataract surgery). 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 NCT07223866, which also lists 6 linked publications.

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 10 Nov 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in