Phacoemulsification at High IOP and Physiologic IOP: Impact on Anterior and Posterior Segment Phy… (NCT05765201) | Clinical Trial Compass
CompletedNot Applicable
Phacoemulsification at High IOP and Physiologic IOP: Impact on Anterior and Posterior Segment Physiology
United States27 participantsStarted 2022-09-22
Plain-language summary
The purpose of this study is to investigate the anterior and posterior structure and functional changes and vascular alterations when performing phacoemulsification at high IOP vs low, more physiological IOP using Centurion® Vision System with Active Sentry® handpiece. These devices are approved by the US Food and Drug Administration (FDA).
Who can participate
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Inclusion Criteria:
* No prior ocular surgery including corneal refractive surgery
* Bilateral visually significant cataract, similar in density (LOCS III grade 2+), undergoing uncomplicated cataract surgery
* Equal dilated pupil size ≥6mm, no use of pupil expansion devices
* Unremarkable systemic health but inclusive of controlled type II diabetes and hypertension with normal OCT angiography at baseline
* A1C ≤ 8% on single monotherapy or lifestyle adjustments
* To maintain high sensitivity/specificity, patients to fall under OCT normative database:
* Axial length 22-26mm
* Refractive error between -5.00D to +5.00D
* Cylinder ≤ 3.00D
* Normal K values \<47.00D
* Axial eye length cannot vary by more than 0.4 mm in an individual patient
* Normal CCT range 540µm ± 50
Exclusion Criteria:
* H/o corneal disease or dystrophies
* Media opacification for reasons other than cataract
* Compromised zonular integrity or stability
* Retinal and retinal vascular pathologies, age-related macular degeneration
* Glaucoma
* Patients with uncontrolled systematic diseases; including hypertension, diabetes, systemic cardiovascular diseases and hematological diseases