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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
10
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.
Chu Vision Institute
Bloomington, Minnesota, United States
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"
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
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
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