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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

27 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-09-22

Study Completion Date

2023-05-04

Brief Summary

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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).

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Detailed Description

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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).

Conditions

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Nuclear Cataract

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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High IOP

Eyes in this arm will maintain an IOP of 65mmHg throughout the cataract surgery.

High IOP

Intervention Type OTHER

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 IOP

Eyes in this arm will maintain an IOP of 28mmHg throughout the cataract surgery.

Low IOP

Intervention Type OTHER

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

Interventions

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High IOP

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

Intervention Type OTHER

Low IOP

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

Intervention Type OTHER

Eligibility Criteria

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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

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes