A Study to Evaluate the Raindrop Near Vision Inlay Under Flap or Within Pocket
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03376412|
Recruitment Status : Recruiting
First Posted : December 18, 2017
Last Update Posted : December 18, 2017
|Condition or disease||Intervention/treatment||Phase|
|Presbyopia||Device: Raindrop Near Vision Inlay||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||The study will be a prospective, single-center, open label clinical trial where a maximum of 60 consecutive non-dominant eyes are implanted with the Raindrop Near Vision Inlay.|
|Masking:||None (Open Label)|
|Masking Description:||No Masking.|
|Official Title:||A Prospective Study to Evaluate the Raindrop Near Vision Inlay in Presbyopes Implanted Under a Corneal Flap or Within a Small-Incision Pocket|
|Actual Study Start Date :||December 8, 2017|
|Estimated Primary Completion Date :||December 2020|
|Estimated Study Completion Date :||December 2020|
Experimental: Single Arm Treatment.
All patients will be unilaterally implanted in the non-dominant eye with the Raindrop Near Vision Inlay for the compensation of presbyopia.
Device: Raindrop Near Vision Inlay
A maximum of 60 consecutive non-dominant eyes will be implanted with the Raindrop Near Vision Inlay.
- Uncorrected Visual Acuity [ Time Frame: 24 Months ]After the inlay procedure, patients will attain functional near acuity in the inlay eye and functional distance vision binocularly.
- Incidence of Corneal Reaction [ Time Frame: 24 Months ]Patients implanted either under a corneal flap or within a small-incision pocket will have minimal incidence of corneal reaction.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03376412
|Contact: Shilpa D. Rose, MD||(301) firstname.lastname@example.org|
|United States, District of Columbia|
|Whitten Laser Eye||Recruiting|
|Washington, District of Columbia, United States, 20016|
|Contact: Shilpa D Rose, MD 301-461-4372 email@example.com|
|Principal Investigator: Shilpa D Rose, MD|
|Principal Investigator: Mark E Whitten, MD|
|Principal Investigator:||Mark E. Whitten, MD||Whitten Laser Eye|