Nuclear CataractNCT06325397
Less Discomfort and Less Pharmacology. Cataract Surgery at Physiologic Intraocular Pressure (IOP)
An observational study of Nuclear Cataract, run by Matthew Rauen at 1 site in United States.
Trial summary
To investigate the impact of high vs low Intraocular Pressure (IOP) on the intraoperative experience for the patient and surgeon. Operating at a more physiologic IOP using Active Sentry hand piece during cataract surgery will result in significantly less discomfort/pain as assessed by the decreased need for rescue… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Nuclear Cataract
- What is being tested?
- High Intraocular Pressure (IOP) and Low Intraocular Pressure (IOP)
- How many people
- 65 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Mar 2024to 1 Apr 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: 75 cataract surgery patients from ophthalmology clinic
Who may be able to join
- Visually significant cataract 2-3+ undergoing uncomplicated cataract surgery
- Unremarkable ocular health but inclusive of early Age related macular degeneration (AMD).
Who cannot join
- History of ocular surgery including corneal refractive surgery
- Compromised zonular integrity or stability
- Uncontrolled diabetes and diabetic retinopathy
- Small pupils
- History of systemic inflammatory disease/uveitis
- History of psychiatric illness, chronic pain/narcotics, benzodiazepine usage
- Abnormal liver or renal function
Trial locations and contacts
1 site in 1 country.
About this study
To investigate the impact of high vs low Intraocular Pressure (IOP) on the intraoperative experience for the patient and surgeon. Operating at a more physiologic IOP using Active Sentry hand piece during cataract surgery will result in significantly less discomfort/pain as assessed by the decreased need for rescue medication
Read the detailed description
Objectives:
To investigate the impact of Intraocular Pressure (IOP) high vs low on the intraoperative experience for the patient and surgeon
Design:
Prospective, single-surgeon, subject's first eyes undergoing phacoemulsification will be randomized to high (Intraocular Pressure (IOP) 65 millimeters of mercury (mmHg)) or low (IOP 25mmHg) IOP, contralateral eye will receive other treatment
Hypothesis:
Operating at a more physiologic IOP using Active Sentry hand piece during cataract surgery will result in significantly less discomfort/pain as assessed by the decreased need for rescue medication
- Conditions
- Nuclear Cataract
- Being tested
- High Intraocular Pressure (IOP), Low Intraocular Pressure (IOP)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Intraocular Pressure (IOP)Other
Prospective, single-surgeon, randomized, paired-eye study; patients undergoing sequential, uncomplicated bilateral phacoemulsification using Active Sentry handpiece® with Intraocular Pressure (IOP) ≤ 24 millimeters of mercury (mmHg) (low IOP) in one eye and with IOP ≥ 65 millimeters of mercury (mmHg) (high IOP) in the other eye.
Low Intraocular Pressure (IOP)Other
Low Intraocular Pressure (IOP) Prospective, single-surgeon, randomized, paired-eye study; patients undergoing sequential, uncomplicated bilateral phacoemulsification using Active Sentry handpiece® with intraocular IOP ≤ 24 millimeters of mercury (mmHg) (low IOP) in one eye and with IOP ≥ 65 millimeters of mercury (mmHg) (high IOP) in the other eye
| Study group | Role | What they receive |
|---|---|---|
| High Intraocular Pressure (IOP) | Eyes in this arm will maintain an Intraocular Pressure (IOP) of 65 millimeters of mercury (mmHg) throughout the cataract surgery. Receives: Other: High Intraocular Pressure (IOP) | |
| Low Intraocular Pressure (IOP) | Eyes in this arm will maintain an Intraocular Pressure (IOP) of 24 millimeters of mercury (mmHg) throughout the cataract surgery. Receives: Other: Low Intraocular Pressure (IOP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Medication Rescue
Percentage (%) of pts in each group requiring treatment for breakthrough discomfort/pain
Measured: Intraoperative
Secondary outcomes (5)
Physiologic Responses associated with pain/inflammation:
Blood pressure- measured systolic pressure over the diastolic pressure
Measured: Intraoperative
Physiologic Responses associated with pain/inflammation:
Pulse rate- measured in beats per minute (bpm)
Measured: Intraoperative
Surgeon Experience: Assessment on patient cooperation
Surgeon assessment on patient cooperation: poor, good, excellent
- Poor cooperation: could not follow instructions, lid squeezing, patient had frequent eye \& head movements
- Good cooperation: able to follow directions 50% of the time, some lid squeezing and patient movement
- Excellent cooperation: able to follow directions >80% of the time with limited lid squeezing and patient movement
Measured: Intraoperative
Surgeon Experience: Surgeon intraoperative experience
Surgeon assessment on overall experience: poor, good, excellent
- Poor: fluctuating chamber (reverse pupillary block or surge) and reduced efficiency (nucleus \& cortex removal)
- Good: >75% chamber stability and adequate efficiency
- Excellent: Minimal to no fluctuating chamber and excellent efficiency
Measured: Intraoperative
Cost- analysis
Cost-analysis on intraoperative pharmacological agents utilized between high vs low Intraocular Pressure (IOP)
Measured: Intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2024
- Study start18 Mar 2024
- Primary completion20 Dec 2024
- Study completion1 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Nuclear CataractStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Matthew Rauen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Matthew Rauen, Wolfe Eye Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06325397
- Sponsor's protocol ID
- IIT #88313865
- Status last verified
- May 2025
- First submitted
- 4 Jan 2024
- Last updated
- 21 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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 9209989Crandall 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 9917782Reddy 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
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Less Discomfort and Less Pharmacology. Cataract Surgery at Physiologic Intraocular Pressure (IOP)
- ClinicalTrials.gov ID
- NCT06325397
- Acronym / sponsor ID
- IIT #88313865
- Conditions
- Nuclear Cataract
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Matthew RauenUniversity, hospital or other
- Study start
- 18 Mar 2024 (actual)
- Primary completion
- 20 Dec 2024 (actual)
- Study completion
- 1 Apr 2025 (actual)
- First posted
- 22 Mar 2024 (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.
To investigate the impact of high vs low Intraocular Pressure (IOP) on the intraoperative experience for the patient and surgeon. Operating at a more physiologic IOP using Active Sentry hand piece during cataract surgery will result in significantly less discomfort/pain as assessed by the decreased need for rescue medication
Detailed description
Objectives:
To investigate the impact of Intraocular Pressure (IOP) high vs low on the intraoperative experience for the patient and surgeon
Design:
Prospective, single-surgeon, subject's first eyes undergoing phacoemulsification will be randomized to high (Intraocular Pressure (IOP) 65 millimeters of mercury (mmHg)) or low (IOP 25mmHg) IOP, contralateral eye will receive other treatment
Hypothesis:
Operating at a more physiologic IOP using Active Sentry hand piece during cataract surgery will result in significantly less discomfort/pain as assessed by the decreased need for rescue medication
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High Intraocular Pressure (IOP) | – | Other: High Intraocular Pressure (IOP)Eyes in this arm will maintain an Intraocular Pressure (IOP) of 65 millimeters of mercury (mmHg) throughout the cataract surgery. |
| Low Intraocular Pressure (IOP) | – | Other: Low Intraocular Pressure (IOP)Eyes in this arm will maintain an Intraocular Pressure (IOP) of 24 millimeters of mercury (mmHg) throughout the cataract surgery. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 75 cataract surgery patients from ophthalmology clinic
Key inclusion criteria (2 listed)
- Visually significant cataract 2-3+ undergoing uncomplicated cataract surgery
- Unremarkable ocular health but inclusive of early Age related macular degeneration (AMD).
Key exclusion criteria (7 listed)
- History of ocular surgery including corneal refractive surgery
- Compromised zonular integrity or stability
- Uncontrolled diabetes and diabetic retinopathy
- Small pupils
- History of systemic inflammatory disease/uveitis
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 |
|---|---|---|
| High Intraocular Pressure (IOP)Prospective, single-surgeon, randomized, paired-eye study; patients undergoing sequential, uncomplicated bilateral phacoemulsification using Active Sentry handpiece® with Intraocular Pressure (IOP) ≤ 24 millimeters of mercury (mmHg) (low IOP) in one eye and with IOP ≥ 65 millimeters of mercury (mmHg) (high IOP) in the other eye. | Other | High Intraocular Pressure (IOP) |
| Low Intraocular Pressure (IOP)Low Intraocular Pressure (IOP) Prospective, single-surgeon, randomized, paired-eye study; patients undergoing sequential, uncomplicated bilateral phacoemulsification using Active Sentry handpiece® with intraocular IOP ≤ 24 millimeters of mercury (mmHg) (low IOP) in one eye and with IOP ≥ 65 millimeters of mercury (mmHg) (high IOP) in the other eye | Other | Low Intraocular Pressure (IOP) |
Primary outcome
Medication Rescue
Time frame: Intraoperative
Percentage (%) of pts in each group requiring treatment for breakthrough discomfort/pain
5 secondary outcomes
Physiologic Responses associated with pain/inflammation:
Time frame: Intraoperative
Physiologic Responses associated with pain/inflammation:
Time frame: Intraoperative
Surgeon Experience: Assessment on patient cooperation
Time frame: Intraoperative
Surgeon Experience: Surgeon intraoperative experience
Time frame: Intraoperative
Cost- analysis
Time frame: Intraoperative
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2025.
- Results publication: PubMed 9209989Gills 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.
- Results publication: PubMed 9917782Crandall 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.
- Results publication: PubMed 34737914Reddy 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.
- Individual participant dataSharing planned: No
Related trials for Nuclear Cataract
RecruitingPhase 2
A Study of CA201A Eye Drops to Prevent Corneal Endothelial Cell Loss in Patients Undergoing Cataract Surgery
Corneal Endothelial Cell Loss, Corneal Endothelial Damage Following the Hard Nuclear Cataract Surgery
Recruiting
This Clinical Trial Compares Two Phacoemulsification Systems Used in a Bilateral Cataract Surgery Subjects in Order to Study CDE and Ultrasound Time During Cataract Removal
Nuclear Sclerosis of the Lens, Phacoemulsification Cataract Surgery
Not yet recruiting
Zero CDE Technique for Lens Removal During FLACS
Cataract With a Nuclear Sclerosis Grade Between 1 to 3
Not yet recruiting
The Impact of Physiologic Cataract Surgery on Patient Comfort and Medication Usage
Cataract and IOL Surgery, Cataract Surgery Anesthesia
Recruiting
Minimal Vitrectomy Surgery for Epiretinal Membrane
Epiretinal Membrane, Macular Edema (ME)
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Nuclear Cataract, 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: finished, as of the sponsor's last update on 21 May 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Medication Rescue (time frame: Intraoperative). 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 NCT06325397, which also lists 3 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 21 May 2025.