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

Sponsor
Matthew Rauen (Other)
Overall Status
Recruiting
CT.gov ID
NCT05765201
Collaborator
(none)
25
Enrollment
1
Location
7.3
Anticipated Duration (Months)
3.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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).

Condition or Disease Intervention/Treatment Phase
  • Other: High IOP
  • Other: Low IOP

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 Design

Study Type:
Observational
Anticipated Enrollment :
25 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Phacoemulsification at High IOP and Physiologic IOP: Impact on Anterior and Posterior Segment Physiology
Actual Study Start Date :
Sep 22, 2022
Anticipated Primary Completion Date :
May 1, 2023
Anticipated Study Completion Date :
May 1, 2023

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. Estimated fluid usage- High IOP Group [Intraoperative]

    Measurement of fluid usage (ml).

  2. Estimated fluid usage- Low IOP Group [Intraoperative]

    Measurement of fluid usage (ml).

Secondary Outcome Measures

  1. Macular Thickness [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 [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Wolfe Eye Clinic West Des Moines Iowa United States 50266

Sponsors and Collaborators

  • Matthew Rauen

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Matthew Rauen, MD, Wolfe Eye Clinic
ClinicalTrials.gov Identifier:
NCT05765201
Other Study ID Numbers:
  • Alcon IIT # 75098433
First Posted:
Mar 13, 2023
Last Update Posted:
Mar 13, 2023
Last Verified:
Feb 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Cataract

Study Results

No Results Posted as of Mar 13, 2023