Status:
COMPLETED
Physiologic Phacofluidics: Ghost Protocol
Lead Sponsor:
Wolfe Eye Clinic
Collaborating Sponsors:
Alcon Research
Conditions:
Cataract
Eligibility:
All Genders
55-95 years
Brief Summary
The goal of this clinical trial is to investigate the early post-operative benefits of performing phacoemulsification at physiologic intraocular pressures. The main questions it aims to answer are: *...
Detailed Description
Methods: Study population Inclusion Criteria * Patients without prior ocular surgery both eyes * Adult patients with visually significant cataract with WHO-World Health Organization NUC grade 2-3 * ...
Eligibility Criteria
Inclusion
- Patients without prior ocular surgery both eyes
- Adult patients with visually significant cataract with WHO-World Health Organization NUC grade 2-3
- First eye only undergoing uncomplicated cataract surgery
- Unremarkable systemic history; controlled diabetes with HbA1c \<7%
- Unremarkable ocular health
- Anterior chamber depth ACD \>2.04mm10
- Age range 55-95
Exclusion
- Prior ocular surgery including corneal refractive surgery, cataract surgery in fellow eye
- Thin corneas (\<490 microns)
- Complicated (use of pupil expansion devices) or prolonged cataract surgeries (\>15 mins) with post-operative complications (IOP spike \>30mmHg), severe punctate keratitis
Key Trial Info
Start Date :
January 1 2024
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 31 2024
Estimated Enrollment :
66 Patients enrolled
Trial Details
Trial ID
NCT06904404
Start Date
January 1 2024
End Date
October 31 2024
Last Update
August 12 2025
Active Locations (1)
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1
Wolfe Eye Clinic Cedar Rapids (Hiawatha)
Hiawatha, Iowa, United States, 52233