Nuclear Cataract
Conditions
Brief summary
To investigate the impact of high vs low Intraocular Pressure (IOP) on the intraoperative experience for the patient and surgeon. Operating at a more physiologic IOP using Active Sentry hand piece during cataract surgery will result in significantly less discomfort/pain as assessed by the decreased need for rescue medication
Detailed description
Objectives: To investigate the impact of Intraocular Pressure (IOP) high vs low on the intraoperative experience for the patient and surgeon Design: Prospective, single-surgeon, subject's first eyes undergoing phacoemulsification will be randomized to high (Intraocular Pressure (IOP) 65 millimeters of mercury (mmHg)) or low (IOP 25mmHg) IOP, contralateral eye will receive other treatment Hypothesis: Operating at a more physiologic IOP using Active Sentry hand piece during cataract surgery will result in significantly less discomfort/pain as assessed by the decreased need for rescue medication
Interventions
OTHERHigh Intraocular Pressure (IOP)
Prospective, single-surgeon, randomized, paired-eye study; patients undergoing sequential, uncomplicated bilateral phacoemulsification using Active Sentry handpiece® with Intraocular Pressure (IOP) ≤ 24 millimeters of mercury (mmHg) (low IOP) in one eye and with IOP ≥ 65 millimeters of mercury (mmHg) (high IOP) in the other eye.
OTHERLow Intraocular Pressure (IOP)
Low Intraocular Pressure (IOP) Prospective, single-surgeon, randomized, paired-eye study; patients undergoing sequential, uncomplicated bilateral phacoemulsification using Active Sentry handpiece® with intraocular IOP ≤ 24 millimeters of mercury (mmHg) (low IOP) in one eye and with IOP ≥ 65 millimeters of mercury (mmHg) (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
* Visually significant cataract 2-3+ undergoing uncomplicated cataract surgery * Unremarkable ocular health but inclusive of early Age related macular degeneration (AMD).
Exclusion criteria
* History of ocular surgery including corneal refractive surgery * Compromised zonular integrity or stability * Uncontrolled diabetes and diabetic retinopathy * Small pupils * History of systemic inflammatory disease/uveitis * History of psychiatric illness, chronic pain/narcotics, benzodiazepine usage * Abnormal liver or renal function
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Medication Rescue | Intraoperative | Percentage (%) of pts in each group requiring treatment for breakthrough discomfort/pain |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Physiologic Responses associated with pain/inflammation: | Intraoperative | Blood pressure- measured systolic pressure over the diastolic pressure |
| Surgeon Experience: Assessment on patient cooperation | Intraoperative | Surgeon assessment on patient cooperation: poor, good, excellent 1. Poor cooperation: could not follow instructions, lid squeezing, patient had frequent eye & head movements 2. Good cooperation: able to follow directions 50% of the time, some lid squeezing and patient movement 3. Excellent cooperation: able to follow directions \>80% of the time with limited lid squeezing and patient movement |
| Surgeon Experience: Surgeon intraoperative experience | Intraoperative | Surgeon assessment on overall experience: poor, good, excellent 1. Poor: fluctuating chamber (reverse pupillary block or surge) and reduced efficiency (nucleus & cortex removal) 2. Good: \>75% chamber stability and adequate efficiency 3. Excellent: Minimal to no fluctuating chamber and excellent efficiency |
| Cost- analysis | Intraoperative | Cost-analysis on intraoperative pharmacological agents utilized between high vs low Intraocular Pressure (IOP) |
Countries
United States
Outcome results
None listed