Quatera 700 vs. Centurion

C

Carolina Eyecare Physicians, LLC

Status

Enrolling

Conditions

Cataract

Treatments

Device: Quatera 700
Device: Centurion

Study type

Interventional

Funder types

Other

Identifiers

NCT06225362
CEP 23-002

Details and patient eligibility

About

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.

Enrollment

40 estimated patients

Sex

All

Ages

50 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Subject is undergoing bilateral lens extraction with implantation of a posterior chamber intraocular lens.
  • Gender: Males and Females.
  • Age: 50 to 80 years old. Solomon KD, DeOliveira A, Sandoval HP 4 CONFIDENTIAL CEP 23-002 Version 1.0/27Jul2023
  • 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.

Exclusion criteria

  • 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).
  • Previous keratoplasty
  • Pupil abnormalities
  • Subject who may reasonably be expected to require a secondary surgical intervention at any time during the study (other than YAG capsulotomy, i.e. LASIK)
  • Anesthesia other than topical anesthesia (i.e. retrobulbar, general, etc).
  • Other ocular procedures at the time of the cataract extraction (i.e., iStent)
  • Any clinically significant, serious or severe medical or psychiatric condition that may increase the risk associated with study participation or may interfere with the interpretation of study results.
  • Participation in (or current participation) any ophthalmic investigational drug or ophthalmic device trial within the previous 30 days prior to the start date of this trial.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

40 participants in 2 patient groups

Quatera 700
Experimental group
Treatment:
Device: Quatera 700
Centurion Vision System
Active Comparator group
Treatment:
Device: Centurion

Trial contacts and locations

1

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Central trial contact

Helga P. Sandoval

Data sourced from clinicaltrials.gov

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