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

Completed

• Conditions: Intraocular Pressure

• Registration Number: NCT07144644
• Lead Sponsor: Research Insight LLC

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.

Study Timeline

• Status Verified: 2024-06
• Study First Submitted: 2024-06-25
• Study Start: 2024-07-26
• Primary Completion: 2025-08-06
• Study Completion: 2025-08-06
• Study First Submitted QC: 2025-08-20
• Last Update Submitted: 2025-08-20
• Study First Posted: 2025-08-27
• Last Update Posted: 2025-08-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 81

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Central Corneal Thickness	1 day following surgery for each eye	Measurement by Pentacam

Secondary Outcome Measures

Name	Time	Method
Total BSS fluid usage during phaco emulsification	Day of surgery for each eye	Balance salt solution fluid usage
Ocular Inflammation	1 day following surgery for each eye	Summed up inflammation score
Aspiration time	Day of surgery for each eye	Aspiration Time

Trial Locations

Locations (1)

Harvard Eye Associates; 🇺🇸 Laguna Hills, California, United States