Clinical Trials Logo
  1. Home
  2. Presbyopia
  3. NCT01373580

A Clinical Trial to Evaluate a Corneal Inlay for the Improvement of Near Vision in Presbyopic Patients

Presbyopia Clinical Trial

Official title:
A Prospective, Multinational Multicenter Clinical Trial to Evaluate the Safety and Effectiveness of the ReVision Optics, Inc. PresbyLens Corneal Inlay for the Improvement of Near Vision in Presbyopic Subjects With MRSE From -0.50 to +1.00

Clinical Trial Summary

This study will be a prospective, multicenter clinical trial in which a total of 400 subjects will be enrolled. All subjects will be followed over a 36 month time frame with a maximum of 15 clinical sites participating. Qualified subjects will provide informed consent for entry into the study.

Clinical Trial Description

The loss of near vision and the ability to perform tasks that require near vision is part of the normal aging process. This natural transformation in the eye occurs as a result of the loss of accommodation of the crystalline lens, a condition known as presbyopia. Presbyopia, characterized by a progressive, age-related loss of accommodation (i.e., the lens ability to focus clearly over a wide range of distances), is most prevalent of all visual deficiencies, affecting 100% of the population over the course of a normal life span. Loss of accommodation begins early in life and, for an emmetropic eye, generally culminates in a complete loss of functional near vision.

ReVision Optics has developed the Raindrop corneal inlay for the correction of near vision. The Raindrop is a 2mm corneal inlay, as small as a pinhead, thinner than a human hair and about 1/500th of a droplet of water. The inlay is the same refractive index as the human cornea. The inlay is placed in the non-dominant eye,centered over the pupil after a corneal flap (LASIK)has been made. The Raindrop is expected to provide presbyopic subjects with improvement of near and intermediate vision. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01373580
Study type Interventional
Source ReVision Optics, Inc.
Contact
Status Completed
Phase N/A
Start date April 2010
Completion date December 2016
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