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

Study Overview
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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).

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).

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

Conditions
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Nuclear Cataract

Intervention / Treatment
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* Other: High IOP
* Other: Low IOP


Participation Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| High IOP<br>Eyes in this arm will maintain an IOP of 65mmHg throughout the cataract surgery. | Other: High IOP<br>* 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<br>|
| Low IOP<br>Eyes in this arm will maintain an IOP of 28mmHg throughout the cataract surgery. | Other: Low IOP<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Estimated fluid usage- High IOP Group | Measurement of fluid usage (ml). | Intraoperative | 
| Estimated fluid usage- Low IOP Group | Measurement of fluid usage (ml). | Intraoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Macular Thickness | Macular thickness measured in microns at week 1, month 1, and month 3. Measured by optical coherence tomography (OCT). | 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. | post procedure at 1 day, 1 week, 1 month, and 3 months |