Trial Outcomes & Findings for Early Feasibility Study to Evaluate the AccuraSee in Correcting Residual Refractive Errors After Cataract Surgery (NCT NCT05113979)

Last Updated: 2024-04-25

Results Overview

Proportion of subjects (≥ 50%) able to achieve MRSE stability within ±0.5D within two consecutive postoperative visits at 1 month or later visits.

Recruitment status

COMPLETED

Target enrollment

10 participants

Primary outcome timeframe

Assessed all postoperative consecutive visit pairings beginning with 1 month visit (1 month to 4 months; 4 months to 1 year); reported for "Postoperative period between 1 month and 1 year"

Results posted on

2024-04-25

Participant Flow

Participants were recruited and enrolled (consented) at three private medical clinics between March 9, 2020 and November 2, 2021.

Of the 12 consented participants, 10 met all study eligibility criteria and were enrolled into the study. Nine met intraoperative eligibility and were treated with the AccuraSee intraocular pseudophakic contact lens (IOPCL) with +3.0D add.

Participant milestones

Participant milestones
Measure	Intent-to-Treat All eligible, enrolled subjects in which the AccuraSee intraocular pseudophakic contact lens (IOPCL) with +3.0D add implantation was attempted
Overall Study STARTED	10
Overall Study COMPLETED	7
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Intent-to-Treat All eligible, enrolled subjects in which the AccuraSee intraocular pseudophakic contact lens (IOPCL) with +3.0D add implantation was attempted
Overall Study Death	2
Overall Study Lost to Follow-up	1

Baseline Characteristics

Early Feasibility Study to Evaluate the AccuraSee in Correcting Residual Refractive Errors After Cataract Surgery

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Intent-to-Treat n=10 Participants All eligible, enrolled subjects in which the AccuraSee intraocular pseudophakic contact lens (IOPCL)with +3.0D add implantation was attempted
Age, Continuous	79.3 Years STANDARD_DEVIATION 8.2 • n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	7 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	10 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Assessed all postoperative consecutive visit pairings beginning with 1 month visit (1 month to 4 months; 4 months to 1 year); reported for "Postoperative period between 1 month and 1 year"

Population: All treated subjects with two or more consecutive postoperative visits

Proportion of subjects (≥ 50%) able to achieve MRSE stability within ±0.5D within two consecutive postoperative visits at 1 month or later visits.

Outcome measures

Outcome measures
Measure	Subjects Treated With AccuraSee IOPCL With +3.0D Add n=8 Participants All subjects treated with AccuraSee intraocular pseudophakic contact lens (IOPCL) with +3.0D add
Subjects With Stable Manifest Refraction Spherical Equivalent (MRSE)	7 Subjects

PRIMARY outcome

Timeframe: 7-14 days visit

Population: All treated subjects that completed the 7-14 days visit

Successful delivery of the AccuraSee IOPCL is defined as: 1) No capsular tear; 2) Visualized centration between the PCIOL and the IOPCL; 3) No visible damage to either the PCIOL or the IOPCL; and 4) Uniform leaflet coverage of all IOPCL haptic tabs

Outcome measures

Outcome measures
Measure	Subjects Treated With AccuraSee IOPCL With +3.0D Add n=9 Participants All subjects treated with AccuraSee intraocular pseudophakic contact lens (IOPCL) with +3.0D add
Subjects With Successful Delivery of AccuraSee IOPCL Capsular tear · No	9 Participants
Subjects With Successful Delivery of AccuraSee IOPCL Capsular tear · Yes	0 Participants
Subjects With Successful Delivery of AccuraSee IOPCL Visualized centration between the PCIOL and IOPCL · No	0 Participants
Subjects With Successful Delivery of AccuraSee IOPCL Visualized centration between the PCIOL and IOPCL · Yes	9 Participants
Subjects With Successful Delivery of AccuraSee IOPCL Visible damage to either the PCIOL or the IOPCL · No	9 Participants
Subjects With Successful Delivery of AccuraSee IOPCL Visible damage to either the PCIOL or the IOPCL · Yes	0 Participants
Subjects With Successful Delivery of AccuraSee IOPCL Uniform leaflet coverage of all IOPCL haptic tabs · No	0 Participants
Subjects With Successful Delivery of AccuraSee IOPCL Uniform leaflet coverage of all IOPCL haptic tabs · Yes	9 Participants

PRIMARY outcome

Timeframe: Assessed at 30-60 days visit and 120-180 days visit, 120-180 days visit reported

Population: All treated subjects that completed the 30-60 days visit and 120-180 days visit.

Safety Endpoint: Minimal change in uniformity of the gap between the pseudophakic intraocular lens (PCIOL) and AccuraSee intraocular pseudophakic contact lens (IOPCL), between 30-60 days and 120-180 days, as determined by ultrasound biomicroscopy (UBM) measurements. Minimal change is defined as +/- 10 microns.

Outcome measures

Outcome measures
Measure	Subjects Treated With AccuraSee IOPCL With +3.0D Add n=8 Participants All subjects treated with AccuraSee intraocular pseudophakic contact lens (IOPCL) with +3.0D add
Long Term Adherence and Positional Stability: Number of Participants With Greater or Less Than +/- 10 Microns Change in Gap Between the Pseudophakic Intraocular Lens and AccuraSee Intraocular Pseudophakic Contact Lens Gap with less than +/- 10 microns change	8 Participants
Long Term Adherence and Positional Stability: Number of Participants With Greater or Less Than +/- 10 Microns Change in Gap Between the Pseudophakic Intraocular Lens and AccuraSee Intraocular Pseudophakic Contact Lens Gap with greater than +/- 10 microns change	0 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline and 330-420 days

Population: All subjects that completed the 330-420 days visit

Change in Uncorrected Distance Visual Acuity (UCDVA) from Baseline measured in lines (5 letters) on ETDRS (Early Treatment Diabetic Retinopathy Study)

Outcome measures

Outcome measures
Measure	Subjects Treated With AccuraSee IOPCL With +3.0D Add n=7 Participants All subjects treated with AccuraSee intraocular pseudophakic contact lens (IOPCL) with +3.0D add
Change in UCDVA From Baseline > 2 lines gained	0 Participants
Change in UCDVA From Baseline 2 lines gained	2 Participants
Change in UCDVA From Baseline 1 line gained	0 Participants
Change in UCDVA From Baseline No change	4 Participants
Change in UCDVA From Baseline 1 line loss	0 Participants
Change in UCDVA From Baseline 2 lines lost	0 Participants
Change in UCDVA From Baseline > 2 lines lost	1 Participants

Adverse Events

Intent-to-Treat

Serious events: 2 serious events

Other events: 2 other events

Deaths: 2 deaths

Serious adverse events

Serious adverse events
Measure	Intent-to-Treat n=10 participants at risk All eligible, enrolled subjects in which the AccuraSee intraocular pseudophakic contact lens (IOPCL) with +3.0D add implantation was attempted
Renal and urinary disorders Death secondary to kidney failure	10.0% 1/10 • Number of events 1 • 12-Months Any untoward or unfavorable medical occurrence, unintended disease or injury, whether or not related to the investigational medical device. All intent-to-treat (ITT) subjects, which underwent IOPCL implantation attempt, were evaluated for adverse events.
Cardiac disorders Death	10.0% 1/10 • Number of events 1 • 12-Months Any untoward or unfavorable medical occurrence, unintended disease or injury, whether or not related to the investigational medical device. All intent-to-treat (ITT) subjects, which underwent IOPCL implantation attempt, were evaluated for adverse events.

Other adverse events

Other adverse events
Measure	Intent-to-Treat n=10 participants at risk All eligible, enrolled subjects in which the AccuraSee intraocular pseudophakic contact lens (IOPCL) with +3.0D add implantation was attempted
Eye disorders Unseated haptic tab	10.0% 1/10 • Number of events 1 • 12-Months Any untoward or unfavorable medical occurrence, unintended disease or injury, whether or not related to the investigational medical device. All intent-to-treat (ITT) subjects, which underwent IOPCL implantation attempt, were evaluated for adverse events.
Eye disorders Failure to implant IOPCL	10.0% 1/10 • Number of events 1 • 12-Months Any untoward or unfavorable medical occurrence, unintended disease or injury, whether or not related to the investigational medical device. All intent-to-treat (ITT) subjects, which underwent IOPCL implantation attempt, were evaluated for adverse events.

Additional Information

Lynne Archer

OnPointVision

Phone: 949-749-4170

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place