Quatera 700 vs. Centurion

Cataract Clinical Trial

Official title:

Evaluation and Clinical Outcomes After Routine Cataract Surgery With the Quatera® 700 and the Centurion® Vision System

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06225362
• Other study ID #: CEP 23-002
• Status: Recruiting
• Phase: N/A
• Start date: January 10, 2024
• Est. completion date: August 30, 2024

Study information

• Verified date: January 2024
• Source: Carolina Eyecare Physicians, LLC
• Contact: Helga P. Sandoval
• Phone: 8438813937
• Email: hps[@]cepmd.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: August 30, 2024
• Est. primary completion date: August 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cataract

Intervention

Device:
• Quatera 700
Phacoemulsification device
• Centurion
Phacoemulsification device

Locations

Country	Name	City	State
United States	Carolina Eyecare Physicians, LLC	Mount Pleasant	South Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Carolina Eyecare Physicians, LLC	Science in Vision

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Central corneal thickness		Postoperative day 1
Primary	Lens removal time	from end of rhexis to complete nucleus removal	Intraoperative