N/A
N=66
Physiologic Phacofluidics: Ghost Protocol
Cataract
Bottom Line
View on ClinicalTrials.gov: NCT06904404 ↗Enrolled (actual)
66
Serious AEs
0.0%
Results posted
Aug 2025
Primary outcome: Primary: Change in Early Post Operative Central Corneal Thickness — 623.9; 650.2 microns
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Cataract surgery at high IOP (Procedure); Cataract surgery at low IOP (Procedure)
- Age
- Adult, Older Adult · 55+ yrs
- Sex
- All
- Sponsor
- Wolfe Eye Clinic
- Primary completion
- Sep 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Early Post Operative Central Corneal Thickness |
623.9; 650.2 | — |
| SECONDARY IL-IB From Aqueous Sample |
0.6130; 0.6806 | — |
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:
* Is there less post operative corneal edema?
* Is there less post operative inflammation?
* Is the post operative vision better? Participants will undergo phacoemulsification cataract surgery with either high or low IOP settings Researchers will compare post op corneal edema, inflammatory marker levels and vision
Eligibility Criteria
Inclusion Criteria
- 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 2.04mm10
- Age range 55-95
Exclusion Criteria
- Prior ocular surgery including corneal refractive surgery, cataract surgery in fellow eye
- Thin corneas ( 15 mins) with post-operative complications (IOP spike >30mmHg), severe punctate keratitis
Data sourced from ClinicalTrials.gov (NCT06904404). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.