Status:
COMPLETED
2311 TURGOR Study -Surgical Efficiency and Postoperative Corneal Clarity With Near Physiologic vs High IOP Settings
Lead Sponsor:
Research Insight LLC
Conditions:
Intraocular Pressure
Eligibility:
All Genders
18+ years
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 ...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 26 2024
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 6 2025
Estimated Enrollment :
81 Patients enrolled
Trial Details
Trial ID
NCT07144644
Start Date
July 26 2024
End Date
August 6 2025
Last Update
August 27 2025
Active Locations (1)
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1
Harvard Eye Associates
Laguna Hills, California, United States, 92563