Trial Outcomes & Findings for Physiologic Phacofluidics: Ghost Protocol (NCT NCT06904404)

Results Overview

4 hours post operatively central corneal thickness assessment

Recruitment status

COMPLETED

Target enrollment

66 participants

Primary outcome timeframe

4 hours post operatively

Results posted on

2025-08-12

Participant Flow

In the recruitment period, 66 subjects were enrolled. One subject, the surgeon deviated from the intra-operative study protocol due to the density of the lens by using additional instrumentation (miLoop) to remove the lens. One subject had CCT performed on the wrong eye, one subject missed their 1-week follow-up visit. Two subjects had CCT readings performed with a Pentacam as opposed to a Lenstar (instrument malfunction).

Unit of analysis: eyes

Participant milestones

Participant milestones
Measure	Low IOP N= 30	High IOP N=31
Overall Study STARTED	33 66	33 66
Overall Study COMPLETED	30 60	31 62
Overall Study NOT COMPLETED	3 6	2 4

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Physiologic Phacofluidics: Ghost Protocol

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Low IOP n=30 Participants Patients randomized to low (20 mmHg) IOP surgical settings using the Active Sentry handpiece	High IOP n=31 Participants Patients randomized to High (65 mmHg) IOP surgical settings using the Active Sentry handpiece	Total n=61 Participants Total of all reporting groups
Age, Continuous	70 years STANDARD_DEVIATION 1.1 • n=5 Participants	70.5 years STANDARD_DEVIATION 0.8 • n=7 Participants	70.2 years STANDARD_DEVIATION 5.5 • n=5 Participants
Sex: Female, Male Female	17 Participants n=5 Participants	18 Participants n=7 Participants	35 Participants n=5 Participants
Sex: Female, Male Male	13 Participants n=5 Participants	13 Participants n=7 Participants	26 Participants n=5 Participants
Race/Ethnicity, Customized Caucasian	30 Participants n=5 Participants	31 Participants n=7 Participants	61 Participants n=5 Participants
Region of Enrollment United States	30 participants n=5 Participants	31 participants n=7 Participants	61 participants n=5 Participants

PRIMARY outcome

Timeframe: 4 hours post operatively

Population: Those that completed all follow-ups

4 hours post operatively central corneal thickness assessment

Outcome measures

Outcome measures
Measure	High IOP Group n=31 Participants Patients randomized to either high (65 mmHg) or low (20 mmHg) IOP surgical settings using the Active Sentry handpiece.	Low IOP Group n=30 Participants Patients randomized to either high (65 mmHg) or low (20 mmHg) IOP surgical settings using the Active Sentry handpiece.
Change in Early Post Operative Central Corneal Thickness	623.9 microns Standard Deviation 9.9	650.2 microns Standard Deviation 11.9

SECONDARY outcome

Timeframe: 2 minutes after cataract surgery completion

Population: Those completed surgery \& follow-ups

Early post op aqueous inflammatory marker of IL-IB level assessment

Outcome measures

Outcome measures
Measure	High IOP Group n=30 Participants Patients randomized to either high (65 mmHg) or low (20 mmHg) IOP surgical settings using the Active Sentry handpiece.	Low IOP Group n=31 Participants Patients randomized to either high (65 mmHg) or low (20 mmHg) IOP surgical settings using the Active Sentry handpiece.
IL-IB From Aqueous Sample	0.6130 pg/ML Standard Deviation 0.0911	0.6806 pg/ML Standard Deviation 0.0935

Adverse Events

Low IOP Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

High IOP Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Edward Hu

Wolfe Eye Clinic

Phone: (319) 362-8032

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place