Post-Approval Study With the KAMRA Inlay

Status Not yet recruiting

Clinical Trial Summary

KAMRA inlay, to be unilaterally implanted into the cornea of a subject's non-dominant eye. The inlay is to be inserted into a stromal pocket created with a surgical femtosecond laser.

Clinical Trial Description

This is a post-approval study of the KAMRA inlay performance and potential device-related issues in a broader population over an extended period of time after pre-market establishment of reasonable safety and effectiveness.

Study objectives include:

- Evaluate the long-term performance (effectiveness) and safety of the device;

- Evaluate real-world performance of the device in subjects treated by refractive surgeons with a range of experience levels;

- Evaluate the performance of the device in racial/ethnic subgroups representative of the population for which the device is intended.

In addition, the data from a subset of the first 105 subjects who have been enrolled in this study will be used to validate the KAMRA Inlay Patient Questionnaire (KIPQ) for the assessment of patients who have received the KAMRA inlay for the treatment of presbyopia. ;

Study Design

Related Conditions & MeSH terms

Presbyopia

Clinical Trial Details

NCT number	NCT03173664
Study type	Observational
Source	AcuFocus, Inc.
Contact	Srividhya Vilupuru, O.D., Ph.D
Phone	949/585-9511
Email	svilupuru@acufocus.com
Status	Not yet recruiting
Phase
Start date	July 31, 2018
Completion date	January 2026

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT05326607` - Pilot Clinical Investigation of Adaptative Eyeglasses for the Correction of Presbyopia	N/A
Recruiting	`NCT06060041` - IC-8 Apthera IOL New Enrollment Post Approval Study
Completed	`NCT05495971` - Extended Depth of Focus Contact Lenses for Presbyopia	N/A
Completed	`NCT05464732` - Vivity IOL: Emmetropia Compared to Monovision.	N/A
Recruiting	`NCT06045299` - Evaluation of the Efficacy and Safety of LNZ101 and LNZ100 for the Presbyopia	Phase 3
Active, not recruiting	`NCT04151550` - Safety & Efficacy of the Laser Scleral Microporation Procedure (Philippines)	N/A
Not yet recruiting	`NCT05506553` - Comparison of Aspheric Toric Intraocular Lenses for Micro-monovision	N/A
Completed	`NCT02554396` - Evaluation of the Efficacy and Safety of PRX-100 in the Treatment of Early to Moderate Presbyopia	Phase 2
Completed	`NCT02214797` - Dispensing Study to Assess Visual Performance of Prototype Contact Lenses	N/A
Completed	`NCT02235831` - DAILIES® AquaComfort Plus® Multifocal (MF) - Comparative Assessment of Visual Performance	N/A
Enrolling by invitation	`NCT01443585` - Clinical Evaluation of a Progressive Addition Lens (PAL)	N/A
Completed	`NCT01591499` - Clinical Evaluation of Biofinity Multifocal Compared With Air Optix Aqua Multifocal and With PureVision Multifocal	N/A
Completed	`NCT04983589` - A Study to Assess Safety and Efficacy in Participants Age 40 to 55 With Presbyopia (Old Eye) Who Receive AGN-190584 in Both Eyes Twice Daily	Phase 3
Completed	`NCT02740010` - The Visual Performances of a Progressive Multifocal Intraocular Lens With Extended Depth of Focus
Recruiting	`NCT05796453` - Post Market Clinical Follow-up (PMCF) Study of Clareon Vivity & Clareon PanOptix	N/A
Completed	`NCT02516306` - A Study to Evaluate the Safety and Efficacy of EV06 Ophthalmic Solution in Improving Vision in Subjects With Presbyopia	Phase 1/Phase 2
Completed	`NCT05359380` - The Impact of Light Conditions on the Efficacy of Multifocal Intraocular Lens Implantation in Activities of Daily Living
Not yet recruiting	`NCT04522427` - Study of Presbyopia-correcting Intraocular Lenses in Eyes With Previous Corneal Refractive Surgery	N/A
Completed	`NCT03688425` - Comparison of Clinical Outcomes POD L GF vs POD F GF in Asian Eyes	N/A
Recruiting	`NCT06053463` - Evaluation of Soft Multifocal Lenses in Presbyopic Previous Contact Lens Wearers	N/A