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Completed

NCT Number: NCT05765201

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

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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Key information

Conditions

Sex eligibility

All sexes

Study type

Observational

Primary location

Wolfe Eye Clinic

West Des Moines, Iowa, 50266, United States

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

High IOP

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

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

Primary outcomes

  1. Estimated fluid usage- High IOP Group

    Time frame: Intraoperative

    Measurement of fluid usage (ml).

  2. Estimated fluid usage- Low IOP Group

    Time frame: Intraoperative

    Measurement of fluid usage (ml).

Secondary outcomes

  1. Macular Thickness

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

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

  2. Corneal Thickness

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

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

Sponsors and collaborators

Lead sponsor

Matthew Rauen

Other

Registry information

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Mar 13, 2023
Registry last updated
Jan 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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