Refractive Errors
Conditions
Brief summary
To determine if the intraocular pseudophakic contact lens (IOPCL), referred to as the AccuraSee, corrects residual refractive errors after cataract surgery using a plus powered lens in subjects with ocular pathology previously implanted with a Bausch and Lomb LI61AO or LI61SE monofocal posterior chamber intraocular lens (PCIOL) and to confirm its positional stability and adherence relative to the PCIOL.
Detailed description
This will be a 12-month study in which a maximum of 10 pseudophakic patients from three clinical sites will be enrolled. All enrolled subjects will receive an AccuraSee IOPCL with +3.0D add to correct residual refractive errors identified after cataract surgery. The primary objective of this study is to determine the stability of the AccuraSee IOPCL to successfully adhere to a pseudophakic intraocular lens (PCIOL) without rotation or slippage. The secondary objective of this study is to determine if the AccuraSee IOPCL can successfully correct refractive errors in subjects previously implanted with a Bausch and Lomb LI61AO and LI61SE monofocal intraocular lens.
Interventions
DEVICEAccuraSee IOPCL with +3.0D add
The IOPCL (intraocular pseudophakic contact lens) consists of a 4.5mm diameter optic. All subjects will receive a +3.0 power regardless of diopter power based on IOL Master. This IOPCL will be coupled to a Bausch and Lomb Model LI61SE or LI61AO intraocular lens to correct residual refractive errors after cataract surgery.
Sponsors
OnPoint Vision Inc
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Treatment with AccuraSee Intraocular Pseudophakic Contact Lens (IOPCL) at least 6-months after cataract surgery with Bausch and Lomb Model LI61A0 and LI61SE
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Subjects who have already had cataract surgery with a Bausch and Lomb monofocal intraocular lens model LI61AO (with lens power from 18.0 diopters (D) to 23.0 D) or model LI61SE monofocal intraocular lens (with a lens power between from18.0 D and 23.0 D), clearly evidenced by photographic documentation with one of the following: (1) patient medical record, (2) clinic chart with labeling attached, (3) surgical record with labeling attached, or (4) patient identification card with make, model, power, and serial number. * Able to comprehend and sign a statement of informed consent. * Willing and able to complete all required postoperative visits. * Subjects who's baseline manifest refraction spherical equivalent (MRSE) is between -0.5D and +3.0D * Best corrected visual acuity 20/80 or worse. * Subjects with ≤1.0D 5D of refractive corneal cylinder * Subjects willing to abstain from pursuing any other surgical vision-correcting procedures for the duration of the study. * Subject must be at least 22 years or older.
Exclusion criteria
* Subjects who have already had cataract surgery with a Toric or multifocal Intraocular Lens. * Subjects who have already had cataract surgery with a Bausch and Lomb monofocal intraocular lens model LI61AO (with a lens power below 18.0 D and greater than 23.0 D) or model LI61SE (with a lens power below 18.0 D and greater than 22.5 D). * Subjects who were treated with an IOL off-label. * Subjects who have MRSE of less than 1.0 Diopter (+1.0 to -1.0 D) and more than +3.0D * Subjects who have more than 1.5D of refractive corneal cylinder * Subjects whose continuous curvilinear capsulorhexis was less than 5mm or more than 6.0 mm in size at the time of IOL surgery. * Subjects who had cataract surgery less than 6 months from the planned date of the IOPCL surgery. * Subjects with anterior capsule fibrosis and phimosis that in the opinion of the investigator may confound the outcome or increase the risk to the subject. * Acute, chronic or uncontrolled systemic or ocular disease that in the opinion of the investigator would increase the operative risk or confound the outcome(s) of the study. * Any corneal abnormality, other than regular corneal astigmatism that in the opinion of the investigator would confound the outcome(s) of the study. * Clinically severe corneal dystrophy (e.g., epithelial, stromal, or endothelial dystrophy). * Microphthalmos. * Previous retinal detachment. * Recurrent severe anterior or posterior segment inflammation of unknown etiology. * Iris neovascularization. * Uncontrolled glaucoma. * Aniridia. * Optic nerve atrophy. * Damaged or incomplete zonules. * Known history of pseudoexfoliation. * Medications that, in the opinion of the investigator, may confound the outcome or increase the risk to the subject (tamsulosin hydrochloride (Flomax)) or other medications with similar side effects (floppy iris syndrome).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Subjects With Stable Manifest Refraction Spherical Equivalent (MRSE) | 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 | Proportion of subjects (≥ 50%) able to achieve MRSE stability within ±0.5D within two consecutive postoperative visits at 1 month or later visits. |
| Subjects With Successful Delivery of AccuraSee IOPCL | 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 |
| 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 | Assessed at 30-60 days visit and 120-180 days visit, 120-180 days visit reported | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change in UCDVA From Baseline | Baseline and 330-420 days | Change in Uncorrected Distance Visual Acuity (UCDVA) from Baseline measured in lines (5 letters) on ETDRS (Early Treatment Diabetic Retinopathy Study) |
Countries
United States
Participant flow
Recruitment details
Participants were recruited and enrolled (consented) at three private medical clinics between March 9, 2020 and November 2, 2021.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Intent-to-Treat All eligible, enrolled subjects in which the AccuraSee intraocular pseudophakic contact lens (IOPCL)with +3.0D add implantation was attempted | 10 |
| Total | 10 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 2 |
| Overall Study | Lost to Follow-up | 1 |
Baseline characteristics
| Characteristic | Intent-to-Treat |
|---|---|
| Age, Continuous | 79.3 Years STANDARD_DEVIATION 8.2 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 7 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 10 Participants |
| Sex: Female, Male Female | 3 Participants |
| Sex: Female, Male Male | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 2 / 10 |
| other Total, other adverse events | 2 / 10 |
| serious Total, serious adverse events | 2 / 10 |
Outcome results
Primary
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
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.
Time frame: 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.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Subjects Treated With AccuraSee 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 |
| Subjects Treated With AccuraSee 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 greater than +/- 10 microns change | 0 Participants |
Primary
Subjects With Stable Manifest Refraction Spherical Equivalent (MRSE)
Proportion of subjects (≥ 50%) able to achieve MRSE stability within ±0.5D within two consecutive postoperative visits at 1 month or later visits.
Time frame: 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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Subjects Treated With AccuraSee IOPCL With +3.0D Add | Subjects With Stable Manifest Refraction Spherical Equivalent (MRSE) | 7 Subjects |
Primary
Subjects With Successful Delivery of AccuraSee IOPCL
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
Time frame: 7-14 days visit
Population: All treated subjects that completed the 7-14 days visit
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Subjects Treated With AccuraSee IOPCL With +3.0D Add | Subjects With Successful Delivery of AccuraSee IOPCL | Capsular tear | No | 9 Participants |
| Subjects Treated With AccuraSee IOPCL With +3.0D Add | Subjects With Successful Delivery of AccuraSee IOPCL | Capsular tear | Yes | 0 Participants |
| Subjects Treated With AccuraSee IOPCL With +3.0D Add | Subjects With Successful Delivery of AccuraSee IOPCL | Visualized centration between the PCIOL and IOPCL | No | 0 Participants |
| Subjects Treated With AccuraSee IOPCL With +3.0D Add | Subjects With Successful Delivery of AccuraSee IOPCL | Visualized centration between the PCIOL and IOPCL | Yes | 9 Participants |
| Subjects Treated With AccuraSee IOPCL With +3.0D Add | Subjects With Successful Delivery of AccuraSee IOPCL | Visible damage to either the PCIOL or the IOPCL | No | 9 Participants |
| Subjects Treated With AccuraSee IOPCL With +3.0D Add | Subjects With Successful Delivery of AccuraSee IOPCL | Visible damage to either the PCIOL or the IOPCL | Yes | 0 Participants |
| Subjects Treated With AccuraSee IOPCL With +3.0D Add | Subjects With Successful Delivery of AccuraSee IOPCL | Uniform leaflet coverage of all IOPCL haptic tabs | No | 0 Participants |
| Subjects Treated With AccuraSee IOPCL With +3.0D Add | Subjects With Successful Delivery of AccuraSee IOPCL | Uniform leaflet coverage of all IOPCL haptic tabs | Yes | 9 Participants |
Other Pre-specified
Change in UCDVA From Baseline
Change in Uncorrected Distance Visual Acuity (UCDVA) from Baseline measured in lines (5 letters) on ETDRS (Early Treatment Diabetic Retinopathy Study)
Time frame: Baseline and 330-420 days
Population: All subjects that completed the 330-420 days visit
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Subjects Treated With AccuraSee IOPCL With +3.0D Add | Change in UCDVA From Baseline | > 2 lines gained | 0 Participants |
| Subjects Treated With AccuraSee IOPCL With +3.0D Add | Change in UCDVA From Baseline | 2 lines gained | 2 Participants |
| Subjects Treated With AccuraSee IOPCL With +3.0D Add | Change in UCDVA From Baseline | 1 line gained | 0 Participants |
| Subjects Treated With AccuraSee IOPCL With +3.0D Add | Change in UCDVA From Baseline | No change | 4 Participants |
| Subjects Treated With AccuraSee IOPCL With +3.0D Add | Change in UCDVA From Baseline | 1 line loss | 0 Participants |
| Subjects Treated With AccuraSee IOPCL With +3.0D Add | Change in UCDVA From Baseline | 2 lines lost | 0 Participants |
| Subjects Treated With AccuraSee IOPCL With +3.0D Add | Change in UCDVA From Baseline | > 2 lines lost | 1 Participants |