Cataract and IOL Surgery, Cataract Surgery Anesthesia, Cataract Surgery Experience, Nuclear Cataract
Conditions
Brief summary
The study will pertain to investigating the impact of high vs low IOP on the intraoperative experience and comfort for the patient and surgeon. Our hypothesis is that operating at a more physiological IOP using Unity VCS/CS and Centurion with Active Sentry at a higher, or more traditional IOP will result in significantly less discomfort/pain as assessed by the decreased need for rescue medication and lower VAS scores.
Detailed description
Objective/ Unmet Medical Need: To investigate the impact of Unity VCS/CS with Intelligent Fluidics at a low IOP setting and Centurion with Active Sentry at a traditionally high IOP setting on the intraoperative experience for the patient and surgeon. Limited research on phacoemulsification at near physiological IOP and its impact on patient discomfort/pain using the Unity VCS/CS system. Design: Prospective, single-surgeon, eyes undergoing phacoemulsification will be randomized to high (IOP 65mmHg) or low (IOP 25mmHg) IOP, contralateral eye will receive other treatment. STUDY HYPOTHESIS Unity VCS/CS with Intelligent Fluidics during cataract surgery will result in significantly less discomfort/pain as assessed by the decreased need for rescue medication and lower VAS scores.
Interventions
DEVICEHigh IOP Setting
Prospective, single-surgeon, eyes undergoing phacoemulsification will be randomized to low (IOP 25mmHg) or high (IOP 65mmHg) IOP, contralateral eye will receive other treatment
DEVICELow IOP Setting
Prospective, single-surgeon, eyes undergoing phacoemulsification will be randomized to low (IOP 25mmHg) or high (IOP 65mmHg) IOP, contralateral eye will receive other treatment
Sponsors
Matthew Rauen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Caregiver)
Intervention model description
Study treatment & Methods: * Sequential cataract surgery with similar cataract grade 2-3+ based on LOCS III grading bilaterally; 2nd eye to be completed within 2-3 weeks of first eye * Randomize first eye to low vs high IOP, contralateral eye receives opposite IOP * Patient education on VAS with standard script * Standard pre-op drops: 2 drops of cyclopentolate 1%, tropicamide 1%, flurbiprofen sodium (Ocufen 0.03%), phenylephrine hydrochloride 2.5%, and 3 drops of marcaine 0.05% * After draping, patients receive OcuCoat on cornea and 3 drops of lidocaine, 1mg of Versed (midazolam for anxiety with no analgesic effects) * If patients experienced breakthrough pain during surgery, additional topical anesthetic, intracameral lidocaine, and/or opioid will be used per surgeon discretion and stage recorded * Physiological responses recorded: Anesthesiologist will monitor patients per standard of care but will record additional BP/HR values at the start of the case (room entry), 4 minutes
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Subjects who will require bilateral cataract surgery will be considered. Evaluations will occur in the clinic of the Principal Investigator (PI) Matthew Rauen, MD at the Wolfe Eye Clinic. Inclusion Criteria: * Visually significant cataract 2-3+ undergoing uncomplicated cataract surgery with similar cataract grade in both eyes * Unremarkable ocular health but inclusive of early AMD
Exclusion criteria
* H/o ocular surgery including corneal refractive surgery * Compromised zonular integrity or stability * Uncontrolled diabetes and diabetic retinopathy * Small pupils * H/o systemic inflammatory disease/uveitis * H/o chronic pain medications (including narcotics) and benzodiazepine usage * Abnormal liver or renal function
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rescue Medication | During cataract surgery | Percent of pts in each group requiring rescue medication for breakthrough discomfort/pain |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Surgeon Intraoperative Experience | During cataract surgery | 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 | During cataract surgery | Cost-analysis on intraoperative medications utilized in high vs low IOP groups |
| Breakthrough pain and discomfort High Axial Length | During cataract surgery | VAS Pain score on subjects with axial length of \>24.5mm VAS score : 0 - no pain, 10 - unbearable pain If patients experienced breakthrough pain during surgery, additional topical anesthetic, intracameral lidocaine, and/or opioid will be used per surgeon discretion and stage of surgery recorded. |
| VAS Pain Score | During Phaco, I/A, and Visco Removal | Discomfort/pain score at phaco, I/A, visco removal. VAS score : 0 - no pain, 10 - unbearable pain |
| Anesthesiologist Review Blood Pressure | During cataract surgery | Physiological responses recorded: Anesthesiologist will monitor patients per standard of care but will record additional Blood Pressure values at the start of the case (room entry), 4 minutes after versed is administered, during phacoemulsification, and during viscoelastic removal. |
| Anesthesiologist Review Pulse Rate | During cataract surgery | Physiological responses recorded: Anesthesiologist will monitor patients per standard of care but will record additional Pulse Rate values at the start of the case (room entry), 4 minutes after versed is administered, during phacoemulsification, and during viscoelastic removal. |
| 1 day Post Op Patient Survey | 1 day post op cataract surgery, each eye | * on experience (Iowa Satisfaction with Anesthesia Scale (ISAS) * on patient preference - What eye was more comfortable? (R/L) * surgical experience did you enjoy more? (R/L) * x% of eyes would undergo the same procedure again * x% of eyes would recommend the procedure to family and friends |
Countries
United States
Contacts
Primary ContactRobyn Kohler, RN
Outcome results
None listed