Phacoemulsification at High IOP and Physiologic IOP: Impact on Anterior and Posterior Segment Physiology

Matthew Rauen27 enrolled

Overview

The purpose of this study is to investigate the anterior and posterior structure and functional changes and vascular alterations when performing phacoemulsification at high IOP vs low, more physiological IOP using Centurion® Vision System with Active Sentry® handpiece. These devices are approved by the US Food and Drug Administration (FDA).

To investigate the anterior and posterior physiological changes when performing phacoemulsification at high IOP vs low, more physiologic IOP using Centurion® Vision System with Active Sentry® handpiece Prospective, single-surgeon, randomized, paired-eye study; patients undergoing sequential, uncomplicated bilateral phacoemulsification using Active Sentry handpiece® with intraocular IOP ≤ 28mmHg (low IOP) in one eye and with IOP ≥ 60mmHg (high IOP) in the other eye Operating at lower, more physiological IOP using Active Sentry® handpiece during cataract surgery will use less BSS fluid usage. (Lower IOP settings are also expected to result in less subclinical changes).

Study Type

OBSERVATIONAL

Enrollment

Conditions

Nuclear Cataract

Interventions

High IOPOTHER

Prospective, single-surgeon, randomized, paired-eye study; patients undergoing sequential, uncomplicated bilateral phacoemulsification using Active Sentry handpiece® with intraocular IOP ≤ 28mmHg (low IOP) in one eye and with IOP ≥ 60mmHg (high IOP) in the other eye

Low IOPOTHER

Eligibility

Sex: ALLHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * No prior ocular surgery including corneal refractive surgery * Bilateral visually significant cataract, similar in density (LOCS III grade 2+), undergoing uncomplicated cataract surgery * Equal dilated pupil size ≥6mm, no use of pupil expansion devices * Unremarkable systemic health but inclusive of controlled type II diabetes and hypertension with normal OCT angiography at baseline * A1C ≤ 8% on single monotherapy or lifestyle adjustments * To maintain high sensitivity/specificity, patients to fall under OCT normative database: * Axial length 22-26mm * Refractive error between -5.00D to +5.00D * Cylinder ≤ 3.00D * Normal K values \<47.00D * Axial eye length cannot vary by more than 0.4 mm in an individual patient * Normal CCT range 540µm ± 50 Exclusion Criteria: * H/o corneal disease or dystrophies * Media opacification for reasons other than cataract * Compromised zonular integrity or stability * Retinal and retinal vascular pathologies, age-related macular degeneration * Glaucoma * Patients with uncontrolled systematic diseases; including hypertension, diabetes, systemic cardiovascular diseases and hematological diseases

Locations (1)

Wolfe Eye Clinic

West Des Moines, Iowa, United States

Outcomes

Primary Outcomes

Estimated fluid usage- High IOP Group

Measurement of fluid usage (ml).

Time frame: Intraoperative

Estimated fluid usage- Low IOP Group

Measurement of fluid usage (ml).

Time frame: Intraoperative

Secondary Outcomes

Macular Thickness

Macular thickness measured in microns at week 1, month 1, and month 3. Measured by optical coherence tomography (OCT).

Time frame: post procedure at 1 week, 1 month, and 3 months

Corneal Thickness

Corneal thickness measured in microns at 1 day, week 1, month 1, and month 3. Measured by pentacam tomography.

Time frame: post procedure at 1 day, 1 week, 1 month, and 3 months

Data from ClinicalTrials.gov

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