Nuclear Cataract
Conditions
Brief 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).
Detailed description
To investigate the anterior and posterior physiological changes when performing phacoemulsification at high IOP vs low, more physiologic IOP using Centurion® Vision System with Active Sentry® handpiece Prospective, single-surgeon, randomized, paired-eye study; patients undergoing sequential, uncomplicated bilateral phacoemulsification using Active Sentry handpiece® with intraocular IOP ≤ 28mmHg (low IOP) in one eye and with IOP ≥ 60mmHg (high IOP) in the other eye Operating at lower, more physiological IOP using Active Sentry® handpiece during cataract surgery will use less BSS fluid usage. (Lower IOP settings are also expected to result in less subclinical changes).
Interventions
OTHERHigh IOP
Prospective, single-surgeon, randomized, paired-eye study; patients undergoing sequential, uncomplicated bilateral phacoemulsification using Active Sentry handpiece® with intraocular IOP ≤ 28mmHg (low IOP) in one eye and with IOP ≥ 60mmHg (high IOP) in the other eye
OTHERLow IOP
Prospective, single-surgeon, randomized, paired-eye study; patients undergoing sequential, uncomplicated bilateral phacoemulsification using Active Sentry handpiece® with intraocular IOP ≤ 28mmHg (low IOP) in one eye and with IOP ≥ 60mmHg (high IOP) in the other eye
Sponsors
Matthew Rauen
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Estimated fluid usage- High IOP Group | Intraoperative | Measurement of fluid usage (ml). |
| Estimated fluid usage- Low IOP Group | Intraoperative | Measurement of fluid usage (ml). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Macular Thickness | post procedure at 1 week, 1 month, and 3 months | Macular thickness measured in microns at week 1, month 1, and month 3. Measured by optical coherence tomography (OCT). |
| Corneal Thickness | post procedure at 1 day, 1 week, 1 month, and 3 months | Corneal thickness measured in microns at 1 day, week 1, month 1, and month 3. Measured by pentacam tomography. |
Countries
United States
Outcome results
None listed