Comparing corneal clarity and thickness after two cataract surgery systems
Unity VCS: A Comparison Study Evaluating Corneal Clarity and Thickness at Day 1 and Day 8 Post Op
This test will see if using a lower eye pressure with the Unity system during cataract surgery leads to fewer side effects and quicker vision recovery than using a higher pressure with the Centurion system for people having cataract surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 105 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Metrolina Eye Associates, PLLC Academic / other |
| Locations | 1 site (Matthews, North Carolina) |
| Trial ID | NCT07222150 on ClinicalTrials.gov |
What this trial studies
Each participant will have sequential bilateral phacoemulsification with similar cataract grades in both eyes, with surgeries completed within about one week. The order of the first surgical eye is randomized; one eye is operated on with the Alcon Unity VCS at a lower intraocular pressure setting (<40) and the fellow eye with the Alcon Centurion VCS with Ozil at a higher pressure setting (≥60). Both devices are FDA‑approved and will be used according to their labels. Outcomes include corneal clarity, corneal thickness, and early visual recovery, with follow‑up lasting about one month.
Who should consider this trial
Good fit: Ideal candidates are adults with cataracts in both eyes of similar severity who do not have glaucoma or corneal disease and can attend the study site for both surgeries and follow‑up.
Not a fit: Patients with glaucoma, pre‑existing corneal disease, or those having only one‑eye surgery are unlikely to benefit or be eligible for this comparison.
Why it matters
Potential benefit: If successful, the lower intraoperative pressure setting with the Unity system could reduce corneal swelling and help patients regain clearer vision sooner after surgery.
How similar studies have performed: Some prior studies suggest lower intraoperative pressures may reduce corneal endothelial stress, but direct head‑to‑head comparisons of these exact systems and settings are limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Cataracts Exclusion Criteria: * Glaucoma, cornea disease
Where this trial is running
Matthews, North Carolina
- Metrolina Eye Associates — Matthews, North Carolina, United States (Recruiting)
Study contacts
- Principal investigator: Ivan Mac, MD — Metrolina Eye Associates
- Study coordinator: Ivan Mac, Md
- Email: imac@metrolinaeye.com
- Phone: 7042341930
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.