Endothelial Cell Density LossZEPTONCT04882189
Study of Endothelial Cell Condition After Cataract Surgery Performed Using Capsulorhexis or ZEPTO
An observational study of Endothelial Cell Density Loss, run by Centricity Vision, Inc. at 4 sites in United States.
Trial summary
This study will use images of the subjects' corneal endothelium obtained using non-invasive specular microscopy to obtain corneal endothelial cell density, the coefficient of variation in endothelial cell size, and the percentage of hexagonal endothelial cells following routine cataract surgery performed using the… Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Endothelial Cell Density Loss
- What is being tested?
- Imaging
- How many people
- 80 participants
- Where
- 4 sitesUnited States
- Study dates
- 23 Aug 2021to 30 May 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Subjects with symptomatic age-related lens cataract desiring lens extraction and IOL implantation.
Who may be able to join
- Subjects consenting to undergoing phacoemulsification and IOL implant surgery for the treatment of symptomatic age-related lens cataract, and then electing to undergo the study,
- Subjects must be willing and able to return for scheduled treatment and follow-up examinations at 1 and 3 months.
Who cannot join
- Pre-existing corneal endothelium pathology
- Presence of guttae
- Narrow angle glaucoma or advanced glaucoma
- Psuedoexfoliation
- Zonular abnormalities
- Corneal endothelial cell density less than 1800 cells/mm2
Show all 15Show fewer
- Uveitis
- Anterior chamber depth less than 2.5mm or greater than 3.75mm
- Cataract grade LOCS II > 3
- Posterior polar cataract
- Planned implantation of IOL > 25D
- Prior ocular surgery in the study eye
- History of medications with potential corneal endothelial cell toxicity
- Any condition that in the surgeon's judgement should exclude the subject from study enrollment.
- Current participation in another drug or device clinical study, or participation in such a clinical study within the prior six months and during the duration of the current study
Trial locations and contacts
4 sites in 1 country.
United States4 sites, 4 recruiting
- Recruiting
UltraVision
Eagle Pass, Texas, 78852
Cinderalla Servin, 210-308-5550, cinderella@lasik2c.com
Tomy Starck, MD
- Recruiting
Houston Eye Associates
Houston, Texas, 77008
Bhavna Shah, 832-553-7113, bshah@houstoneye.com
Kevin Jong, MD
- Recruiting
Houston Eye Associates
Houston, Texas, 77025
Marcel Belloso, 713-668-6828, mailto:mbelloso@houstoneye.com
Mark Vital, MD
- Recruiting
UltraVision
San Antonio, Texas, 78256
Cinderalla Servin, 210-308-5550, cinderella@lasik2c.com
Tomy Starck, MD
About this study
Official title: A Prospective Randomized Controlled Masked Study of Endothelial Cell Condition After Cataract Surgery Performed Using Manual Capsulorhexis or the ZEPTO Precision Capsulotomy System
This study will use images of the subjects' corneal endothelium obtained using non-invasive specular microscopy to obtain corneal endothelial cell density, the coefficient of variation in endothelial cell size, and the percentage of hexagonal endothelial cells following routine cataract surgery performed using the standard method of manual capsulorhexis compared to cataract surgery performed using Zepto Precision Capsulotomy System.
- Conditions
- Endothelial Cell Density Loss
- Being tested
- Imaging
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ImagingDiagnostic test
Images of the corneal endothelium will be obtained using specular microscopy at 1- and 3-months post cataract surgery.
| Study group | Role | What they receive |
|---|---|---|
| Capsulorhexis | Capsulotomies conducted by Capsulorhexis Receives: Diagnostic Test: Imaging | |
| ZEPTO Precision Capsulotomy Device | Capsulotomies conducted by ZEPTO Precision Capsulotomy Device Receives: Diagnostic Test: Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Endothelial Cell Density Loss
Post Cataract Surgery
Measured: 3 months
Secondary outcomes (3)
Endothelial Cell Density Loss
Post Cataract Surgery
Measured: 1 month
Coefficient of Variation in Endothelial Cell Size
Post Cataract Surgery
Measured: 1 and 3 months
% of hexagonal cells
Post Cataract Surgery
Measured: 1 and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2021
- Study start23 Aug 2021
- Primary completion30 Mar 2022 (estimated)
- Study completion30 May 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endothelial Cell Density LossStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centricity Vision, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04882189
- Sponsor's protocol ID
- 13803
- Acronym
- ZEPTO
- Status last verified
- Mar 2022
- First submitted
- 6 May 2021
- Last updated
- 22 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Controlled Masked Study of Endothelial Cell Condition After Cataract Surgery Performed Using Manual Capsulorhexis or the ZEPTO Precision Capsulotomy System
- ClinicalTrials.gov ID
- NCT04882189
- Acronym / sponsor ID
- ZEPTO / 13803
- Conditions
- Endothelial Cell Density Loss
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Centricity Vision, Inc.Industry (pharma, biotech, devices)
- Study start
- 23 Aug 2021 (actual)
- Primary completion
- 30 Mar 2022 (estimated)
- Study completion
- 30 May 2022 (estimated)
- First posted
- 11 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will use images of the subjects' corneal endothelium obtained using non-invasive specular microscopy to obtain corneal endothelial cell density, the coefficient of variation in endothelial cell size, and the percentage of hexagonal endothelial cells following routine cataract surgery performed using the standard method of manual capsulorhexis compared to cataract surgery performed using Zepto Precision Capsulotomy System.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Capsulorhexis | – | Diagnostic Test: ImagingCapsulotomies conducted by Capsulorhexis |
| ZEPTO Precision Capsulotomy Device | – | Diagnostic Test: ImagingCapsulotomies conducted by ZEPTO Precision Capsulotomy Device |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects with symptomatic age-related lens cataract desiring lens extraction and IOL implantation.
Key inclusion criteria (2 listed)
- Subjects consenting to undergoing phacoemulsification and IOL implant surgery for the treatment of symptomatic age-related lens cataract, and then electing to undergo the study,
- Subjects must be willing and able to return for scheduled treatment and follow-up examinations at 1 and 3 months.
Key exclusion criteria (15 listed)
- Pre-existing corneal endothelium pathology
- Presence of guttae
- Narrow angle glaucoma or advanced glaucoma
- Psuedoexfoliation
- Zonular abnormalities
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 |
|---|---|---|
| ImagingImages of the corneal endothelium will be obtained using specular microscopy at 1- and 3-months post cataract surgery. | Diagnostic test | Capsulorhexis, ZEPTO Precision Capsulotomy Device |
Primary outcome
Endothelial Cell Density Loss
Time frame: 3 months
Post Cataract Surgery
3 secondary outcomes
Endothelial Cell Density Loss
Time frame: 1 month
Coefficient of Variation in Endothelial Cell Size
Time frame: 1 and 3 months
% of hexagonal cells
Time frame: 1 and 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2022.
- Individual participant dataSharing planned: Undecided
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.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Endothelial Cell Density Loss, run by Centricity Vision, Inc. at 4 sites 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 2 inclusion and 15 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: status not confirmed, as of the sponsor's last update on 22 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Endothelial Cell Density Loss (time frame: 3 months). 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 22 Mar 2022; AzTrials last refreshed its copy on 31 Oct 2026.