CataractNCT06225362
Quatera 700 vs. Centurion
A study testing Quatera 700 and Centurion in people with Cataract, run by Carolina Eyecare Physicians, LLC at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Cataract
- What is being tested?
- Quatera 700 and Centurion
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Jan 2024to 6 Oct 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 22Show fewer
- 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 locations and contacts
1 site in 1 country.
United States1 site
Carolina Eyecare Physicians, LLC
Mt. Pleasant, South Carolina, 29464
About this study
Official title: Evaluation and Clinical Outcomes After Routine Cataract Surgery With the Quatera® 700 and the Centurion® Vision System
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.
- Conditions
- Cataract
- Being tested
- Quatera 700, Centurion
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quatera 700Device
Phacoemulsification device
CenturionDevice
Phacoemulsification device
| Study group | Role | What they receive |
|---|---|---|
| Quatera 700 | Experimental | Not described Receives: Device: Quatera 700 |
| Centurion Vision System | Active comparator | Not described Receives: Device: Centurion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Central Corneal Thickness
Ultrasound pachymetry
Measured: Postoperative day 1
Lens Removal Time
from end of rhexis to complete nucleus removal
Measured: Intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2024
- Study start10 Jan 2024
- Primary completion6 Oct 2025
- Study completion6 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for CataractStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Carolina Eyecare Physicians, LLC
- Sponsor type
- University, hospital or other
- Collaborators
- Science in Vision
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06225362
- Sponsor's protocol ID
- CEP 23-002
- Status last verified
- Mar 2026
- First submitted
- 16 Jan 2024
- Last updated
- 1 Apr 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation and Clinical Outcomes After Routine Cataract Surgery With the Quatera® 700 and the Centurion® Vision System
- ClinicalTrials.gov ID
- NCT06225362
- Acronym / sponsor ID
- CEP 23-002
- Conditions
- Cataract
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Carolina Eyecare Physicians, LLCUniversity, hospital or other
- Collaborators
- Science in Vision
- Study start
- 10 Jan 2024 (actual)
- Primary completion
- 6 Oct 2025 (actual)
- Study completion
- 6 Oct 2025 (actual)
- First posted
- 25 Jan 2024 (actual)
- Results
- Posted 1 Apr 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Quatera 700 | Experimental | Device: Quatera 700 |
| Centurion Vision System | Active comparator | Device: Centurion |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (22 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Quatera 700Phacoemulsification device | Device | Quatera 700 |
| CenturionPhacoemulsification device | Device | Centurion Vision System |
Primary outcome
Central Corneal Thickness
Time frame: Postoperative day 1
Ultrasound pachymetry
Lens Removal Time
Time frame: Intraoperative
from end of rhexis to complete nucleus removal
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Cataract
Active, not recruitingObservational study
Age-Related Eye Disease Study (AREDS) Follow-Up
Age-Related Macular Degeneration, Cataract
RecruitingObservational study
Anterior Segment Anatomy Assessed by Swept-Source OCT in Ocular Surgery Patients
Cataract, Primary Angle-Closure Glaucoma
RecruitingObservational study
Surgical Procedure Efficiency Evaluation stuDy
Cataract, Vitreous Hemorrhage
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
Recruiting
Trial Comparing miLOOP Device Assisted Phacoemulsification vs Standard Surgery for Dense Cataracts: Effects on Endothelial Cell Loss, Energy Use, and Vision Recovery
Cataract, Endothelial Cell Density
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Quatera 700 and Centurion in people with Cataract, run by Carolina Eyecare Physicians, LLC at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Apr 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Central Corneal Thickness (time frame: Postoperative day 1). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2026.