2311 TURGOR Study -Surgical Efficiency and Postoperative Corneal Clarity With Near Physiologic vs High IOP Settings

NCT07144644 | Completed FDA Device

• 1 other identifier: 2311
• Study Type: observational
• Target: 81
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Intraocular Pressure

Outcome Measures

Primary Outcomes (1)

• Central Corneal Thickness

  Measurement by Pentacam

  1 day following surgery for each eye

Secondary Outcomes (3)

• Ocular Inflammation

  1 day following surgery for each eye

• Total BSS fluid usage during phaco emulsification

  Day of surgery for each eye

• Aspiration time

  Day of surgery for each eye

Other Outcomes (8)

• BSS usage (Total)

  Day of surgery for each eye

• Ultrasound time

  Day of surgery for each eye

• Use of opioids during cataract surgery

  Day of surgery for each eye

Interventions

Adjusting intraocular pressure (IOP) settings DEVICE

Investigating whether adjusting IOP settings near physiologic levels during cataract surgery could potentially lead to better surgical outcomes

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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)

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Research Insight LLC: lead

Study Sites (1)

Harvard Eye Associates

Laguna Hills, California, 92563, United States

Location

Study Officials

• John Hovanesian, MD

  Harvard Eye Associates

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 25, 2024
• First Posted: August 27, 2025
• Study Start: July 26, 2024
• Primary Completion: August 6, 2025
• Study Completion: August 6, 2025
• Last Updated: August 27, 2025

Record last verified: 2024-06

Locations

US (1)