Clinical Trials Logo

Clinical Trial Summary

The clinical objective of this study is to evaluate the Raindrop® Near Vision Inlay for the improvement of near vision in presbyopic or pseudophakic patients treated with low dose Mitomycin C immediately following femtosecond flap creation.


Clinical Trial Description

The scientific objective of this study is to evaluate the postoperative incidence of corneal reaction in patients treated with low dose Mitomycin C, immediately following femtosecond flap creation (LASIK correction if needed), and before implantation with the Raindrop corneal inlay in the non-dominant eye. The postoperative incidence of haze, visible by broad tangential illumination of the slit lamp, is known to adversely impact the safety and efficacy of the Raindrop corneal inlay. Three main strategies have been employed to minimize haze incidence after surgery: (i) perfection of the surgical technique, (ii) deeper implantation in the cornea, and (iii) extension of the steroid regimen after surgery. Haze has also been observed after another type of corneal refractive procedure, Photorefractive Keratectomy (PRK). Several prospective studies have shown that Mitomycin C, applied immediately following the PRK laser procedure, is effective in reducing the postoperative incidence of haze. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03101501
Study type Interventional
Source Key-Whitman Eye Center
Contact
Status Terminated
Phase Phase 4
Start date February 14, 2017
Completion date February 1, 2018

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 NCT02235831 - DAILIES® AquaComfort Plus® Multifocal (MF) - Comparative Assessment of Visual Performance N/A
Completed NCT02214797 - Dispensing Study to Assess Visual Performance of Prototype Contact Lenses 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