NCT06225362

Brief Summary

Phacoemulsification is the most common treatment for cataract surgery in the developed countries and over the years it gained importance due to several factors: small incision, surgery performed under topical anesthesia - which reduce injection-related complications - short recovery time, low post operatory induced astigmatism, and low incidence of surgical complications, when compared to the conventional surgeries. The study evaluates 2 different phacoemulsification devices in patients undergoing routine cataract surgery in both eyes.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2024

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 10, 2024

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

January 16, 2024

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 25, 2024

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 6, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 6, 2025

Completed
6 months until next milestone

Results Posted

Study results publicly available

April 1, 2026

Completed
Last Updated

April 1, 2026

Status Verified

March 1, 2026

Enrollment Period

1.7 years

First QC Date

January 16, 2024

Results QC Date

February 20, 2026

Last Update Submit

March 12, 2026

Conditions

Cataract

Outcome Measures

Primary Outcomes (2)

  • Central Corneal Thickness

    Ultrasound pachymetry

    Postoperative day 1

  • Lens Removal Time

    from end of rhexis to complete nucleus removal

    Intraoperative

Study Arms (2)

Quatera 700

EXPERIMENTAL
Device: Quatera 700

Centurion Vision System

ACTIVE COMPARATOR
Device: Centurion

Interventions

Quatera 700DEVICE

Phacoemulsification device

Quatera 700
CenturionDEVICE

Phacoemulsification device

Centurion Vision System

Eligibility Criteria

Age50 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subject is undergoing bilateral lens extraction with implantation of a posterior chamber intraocular lens.
  • Gender: Males and Females.
  • Age: 50 to 80 years old.
  • Willing and able to provide written informed consent for participation in the study
  • Willing and able to comply with scheduled visits and other study procedures.
  • Scheduled to undergo standard cataract surgery with topical anesthesia in both eyes within 1 to 30 days between surgeries
  • Subjects requiring an IOL power in the range of +10.0 D to +30.0 D only.
  • Potential postoperative visual acuity of 0.2 logMAR (20/32 Snellen) or better in both eyes.

You may not qualify if:

  • Severe preoperative ocular pathology: amblyopia, rubella cataract, proliferative diabetic retinopathy, shallow anterior chamber, macular edema, retinal detachment, aniridia or iris atrophy, uveitis, history of iritis, iris neovascularization, medically uncontrolled glaucoma, microphthalmos or macrophthalmos, optic nerve atrophy, macular degeneration (with anticipated best postoperative visual acuity less than 20/30), advanced glaucomatous damage, etc.
  • Uncontrolled diabetes.
  • Use of any systemic or topical drug known to interfere with visual performance.
  • Contact lens use during the active treatment portion of the trial.
  • Any concurrent infectious/non-infectious conjunctivitis, keratitis or uveitis.
  • Clinically significant corneal dystrophy.
  • Corneal irregularities potentially affecting visual acuity: keratoconus, corneal dystrophy, corneal opacities.
  • Endothelial cell count less than 1500 cells/mm2
  • History of chronic intraocular inflammation.
  • History of retinal detachment.
  • Femtosecond arcuates at time of surgery.
  • Femtosecond laser assisted cataract surgery in one eye only.
  • Pseudoexfoliation syndrome or any other condition that has the potential to weaken the zonules.
  • Previous intraocular surgery.
  • Previous radial keratoromy (RK).
  • +7 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Carolina Eyecare Physicians, LLC

Mt. Pleasant, South Carolina, 29464, United States

Location

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens DiseasesEye Diseases

Results Point of Contact

Title
Director of Clinical Trials
Organization
Carolina Eyecare Physicians, LLC
hps@cepmd.com
8438813937

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 16, 2024

First Posted

January 25, 2024

Study Start

January 10, 2024

Primary Completion

October 6, 2025

Study Completion

October 6, 2025

Last Updated

April 1, 2026

Results First Posted

April 1, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)