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

NCT ID: NCT07144644

Last Updated: 2025-08-27

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 81 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-07-26
• Study Completion Date: 2025-08-06

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.

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

Interventions

Adjusting intraocular pressure (IOP) settings

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

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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)

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Research Insight LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

John Hovanesian, MD

Role: PRINCIPAL_INVESTIGATOR

Harvard Eye Associates

Locations

Harvard Eye Associates

Laguna Hills, California, United States

Countries

United States

Other Identifiers

2311

Identifier Type: -

Identifier Source: org_study_id