Intraocular PressureNCT07144644
2311 TURGOR Study -Surgical Efficiency and Postoperative Corneal Clarity With Near Physiologic vs High IOP Settings
An observational study of Intraocular Pressure, run by Research Insight LLC at 1 site in United States.
Trial summary
The study aims to investigate whether adjusting intraocular pressure (IOP) settings to near physiologic levels during cataract surgery could potentially lead to better surgical outcomes, particularly in terms of corneal clarity in the post-operative period. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intraocular Pressure
- What is being tested?
- Adjusting intraocular pressure (IOP) settings
- Type of treatment
- Medical device
- How many people
- 81 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Jul 2024to 6 Aug 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 18 years and older
- All sexes
- Adult, Older adult
Study population: This will be a multisite, prospective, randomized, contralateral-eye controlled, open-label clinical study, in which a maximum of 160 eyes will be treated with the Alcon Centurion System with Active Sentry during cataract surgery.
Who may be able to join
- Patients with cataract and otherwise healthy eyes, not exhibiting any significant ocular morbidity that would be expected to influence outcome measures.
- Patients undergoing phacoemulsification surgery (OU) with or without femtosecond laser assistance (OU) with the Alcon Centurion system using Active Sentry handpieces (both eyes must undergo same treatment) . The cataract surgery and the use of the medical device(s) are planned by the principal investigator and are a part of regular care and are received regardless of being a part the study.
- Patients expected to undergo sequential cataract surgery in both eyes within 6 weeks of each other.
- Patients with the same LOCS III scale of nuclear portion of cataract in both eyes
- Patients whose eyes will both be operated by the same surgeon using a similar Centurion machine with similar wound architecture and size, viscoelastic, technique, and postoperative medications.
- Axial eye length cannot vary between eyes by more than 0.4 mm in an individual patient.
- At least 30% of patients with PanOptix, 30% Vivity and 30% monofocal IOLs (no mix and match)
Who cannot join
- Patients with visually significant co-morbidities (corneal, retina, optic nerve disease) that could affect the surgical outcome measures.
- Clinically significant ocular trauma.
- Patients with unusually dense cataract (4+ nuclear sclerosis), zonular instability, or pseudoexfoliation syndrome
- Patients requiring mechanical pupil expanding devices (iris hooks, Malyugin rings, etc.)
- Patients with surgical complications either during or after surgery (capsule tears, iris trauma, decentered IOL)
- Ocular surgery (e.g., intraocular, oculoplastic, corneal or refractive surgical procedure performed within the last 3 months or at any time that in the investigator's clinical judgment if it would interfere with the outcome measures of this study.
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- Reported pre-existing anxiety or pain disorder or history of psychiatric illness, chronic pain/narcotics, benzodiazepine usage.
- Epitheliopathy/ Epithelial complications intraoperatively that may in the opinion of the investigator affect corneal densitometry or edema postoperatively.
- Clinically significant IOL decentration
- Vulnerable populations which includes, but is not limited to potential subjects who are children, prisoners, pregnant women, mentally disabled persons, and economically and educationally disadvantaged persons.
Trial locations and contacts
1 site in 1 country.
United States1 site
Harvard Eye Associates
Laguna Hills, California, 92563
About this study
Official title: Surgical Efficiency and Postoperative Corneal Clarity With Near Physiologic vs High IOP Settings
The study aims to investigate whether adjusting intraocular pressure (IOP) settings to near physiologic levels during cataract surgery could potentially lead to better surgical outcomes, particularly in terms of corneal clarity in the post-operative period.
Read the detailed description
The study aims to investigate whether adjusting intraocular pressure (IOP) settings to near physiologic levels during cataract surgery could potentially lead to better surgical outcomes, particularly in terms of corneal clarity in the post-operative period. By comparing these two different IOP settings, we can determine the impact of IOP on surgical efficiency and the quality of post-operative results, especially in relation to corneal health.
- Conditions
- Intraocular Pressure
- Being tested
- Adjusting intraocular pressure (IOP) settings
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adjusting intraocular pressure (IOP) settingsDevice
Investigating whether adjusting IOP settings near physiologic levels during cataract surgery could potentially lead to better surgical outcomes
What is being measured
The primary outcome is the main question the study is designed to answer.
Central Corneal Thickness
Measurement by Pentacam
Measured: 1 day following surgery for each eye
Secondary outcomes (3)
Ocular Inflammation
Summed up inflammation score
Measured: 1 day following surgery for each eye
Total BSS fluid usage during phaco emulsification
Balance salt solution fluid usage
Measured: Day of surgery for each eye
Aspiration time
Aspiration Time
Measured: Day of surgery for each eye
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2025
- Study start26 Jul 2024
- Primary completion6 Aug 2025
- Study completion6 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intraocular PressureStudies 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
- Cross-sectional
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- Research Insight LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- John Hovanesian, MD, Principal investigator, Harvard Eye Associates
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07144644
- Sponsor's protocol ID
- 2311
- Status last verified
- Jun 2024
- First submitted
- 25 Jun 2024
- Last updated
- 27 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surgical Efficiency and Postoperative Corneal Clarity With Near Physiologic vs High IOP Settings
- ClinicalTrials.gov ID
- NCT07144644
- Acronym / sponsor ID
- 2311
- Conditions
- Intraocular Pressure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- Research Insight LLCIndustry (pharma, biotech, devices)
- Study start
- 26 Jul 2024 (actual)
- Primary completion
- 6 Aug 2025 (actual)
- Study completion
- 6 Aug 2025 (actual)
- First posted
- 27 Aug 2025 (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 study aims to investigate whether adjusting intraocular pressure (IOP) settings to near physiologic levels during cataract surgery could potentially lead to better surgical outcomes, particularly in terms of corneal clarity in the post-operative period.
Detailed description
The study aims to investigate whether adjusting intraocular pressure (IOP) settings to near physiologic levels during cataract surgery could potentially lead to better surgical outcomes, particularly in terms of corneal clarity in the post-operative period. By comparing these two different IOP settings, we can determine the impact of IOP on surgical efficiency and the quality of post-operative results, especially in relation to corneal health.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- This will be a multisite, prospective, randomized, contralateral-eye controlled, open-label clinical study, in which a maximum of 160 eyes will be treated with the Alcon Centurion System with Active Sentry during cataract surgery.
Key inclusion criteria (7 listed)
- Patients with cataract and otherwise healthy eyes, not exhibiting any significant ocular morbidity that would be expected to influence outcome measures.
- Patients undergoing phacoemulsification surgery (OU) with or without femtosecond laser assistance (OU) with the Alcon Centurion system using Active Sentry handpieces (both eyes must undergo same treatment) . The cataract surgery and the use of the medical device(s) are planned by the principal investigator and are a part of regular care and are received regardless of being a part the study.
- Patients expected to undergo sequential cataract surgery in both eyes within 6 weeks of each other.
- Patients with the same LOCS III scale of nuclear portion of cataract in both eyes
- Patients whose eyes will both be operated by the same surgeon using a similar Centurion machine with similar wound architecture and size, viscoelastic, technique, and postoperative medications.
Key exclusion criteria (10 listed)
- Patients with visually significant co-morbidities (corneal, retina, optic nerve disease) that could affect the surgical outcome measures.
- Clinically significant ocular trauma.
- Patients with unusually dense cataract (4+ nuclear sclerosis), zonular instability, or pseudoexfoliation syndrome
- Patients requiring mechanical pupil expanding devices (iris hooks, Malyugin rings, etc.)
- Patients with surgical complications either during or after surgery (capsule tears, iris trauma, decentered IOL)
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 |
|---|---|---|
| Adjusting intraocular pressure (IOP) settingsInvestigating whether adjusting IOP settings near physiologic levels during cataract surgery could potentially lead to better surgical outcomes | Device | – |
Primary outcome
Central Corneal Thickness
Time frame: 1 day following surgery for each eye
Measurement by Pentacam
3 secondary outcomes
Ocular Inflammation
Time frame: 1 day following surgery for each eye
Total BSS fluid usage during phaco emulsification
Time frame: Day of surgery for each eye
Aspiration time
Time frame: Day of surgery for each eye
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 27 Aug 2025.
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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. This study is not recruiting at the moment.
John Hovanesian, MD principal investigator
Harvard Eye Associates
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 Intraocular Pressure, run by Research Insight LLC 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 7 inclusion and 10 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 27 Aug 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?
Central Corneal Thickness (time frame: 1 day following surgery for each eye). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Aug 2025.