NCT05113979

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

Early Feasibility Study to Evaluate the Safety and Effectiveness of the AccuraSee for Secondary Implantation in the Capsular Bag to Correct Residual Refractive Errors of Previous Cataract Surgery

• Status: Completed
• Phase: —
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: OnPoint Vision Inc · Industry
• Sex: All
• Age: 22 Years
• Healthy volunteers: Accepted

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.

Conditions

• Refractive Errors

Interventions

Type	Name	Description
DEVICE	AccuraSee 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.

Timeline

• Start date: 2020-03-09
• Primary completion: 2022-09-09
• Completion: 2022-09-09
• First posted: 2021-11-09
• Last updated: 2024-04-25
• Results posted: 2024-04-25

Locations

1 site across 1 country: United States