Health TrialsbyHealthPanel

The Impact of Physiologic Cataract Surgery on Patient Comfort and Medication Usage

ConditionsCataract and IOL SurgeryCataract Surgery AnesthesiaCataract Surgery ExperienceNuclear Cataract
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age60+
SponsorMatthew Rauen

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Visually significant cataract 2-3+ undergoing uncomplicated cataract surgery with similar cataract grade in both eyes

Unremarkable ocular health but inclusive of early AMD

Disqualifiers

H/o ocular surgery including corneal refractive surgery

Compromised zonular integrity or stability

Uncontrolled diabetes and diabetic retinopathy

Small pupils

Trial design

Design model

Parallel

Treatments tested in this trial

  • High IOP Setting

    Device

    Prospective, single-surgeon, eyes undergoing phacoemulsification will be randomized to low (IOP 25mmHg) or high (IOP 65mmHg) IOP, contralateral eye will receive other treatment

  • Low IOP Setting

    Device

    Prospective, single-surgeon, eyes undergoing phacoemulsification will be randomized to low (IOP 25mmHg) or high (IOP 65mmHg) IOP, contralateral eye will receive other treatment

Treatment groups

85 Participants
are divided into 2 treatment groups
Group A: Centurion with Active Sentry at a traditionally high IOP settingActive comparator 1 intervention
Group B: Unity VCS/CS with Intelligent Fluidics at a low IOP settingActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Rescue Medication

Percent of pts in each group requiring rescue medication for breakthrough discomfort/pain

Time frame
During cataract surgery

Secondary outcomes

1

VAS Pain Score

Discomfort/pain score at phaco, I/A, visco removal. VAS score : 0 - no pain, 10 - unbearable pain

Time frame
During Phaco, I/A, and Visco Removal
2

Surgeon Intraoperative Experience

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

Time frame
During cataract surgery
3

Cost Analysis

Cost-analysis on intraoperative medications utilized in high vs low IOP groups

Time frame
During cataract surgery
4

Breakthrough pain and discomfort High Axial Length

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.

Time frame
During cataract surgery

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Matthew Rauen

Lead sponsor

Wolfe Eye Clinic

Sponsor institution

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: