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

January 4, 2024 updated by: Matthew Rauen
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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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 (Actual)

27

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Iowa
      • West Des Moines, Iowa, United States, 50266
        • Wolfe Eye Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

25 cataract surgery patients form ophthalmology clinic.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
High IOP
Eyes in this arm will maintain an IOP of 65mmHg throughout the cataract surgery.
Other: 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
Low IOP
Eyes in this arm will maintain an IOP of 28mmHg throughout the cataract surgery.
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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
post procedure at 1 week, 1 month, and 3 months
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.
post procedure at 1 day, 1 week, 1 month, and 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Matthew Rauen

Investigators

  • Principal Investigator: Matthew Rauen, MD, Wolfe Eye Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 22, 2022

Primary Completion (Actual)

May 4, 2023

Study Completion (Actual)

May 4, 2023

Study Registration Dates

First Submitted

January 17, 2023

First Submitted That Met QC Criteria

February 28, 2023

First Posted (Actual)

March 13, 2023

Study Record Updates

Last Update Posted (Actual)

January 8, 2024

Last Update Submitted That Met QC Criteria

January 4, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Alcon IIT # 75098433

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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