A Prospective Study To Evaluate The Raindrop Near Vision Inlay In Presybopic or Pseudophakic Patients Treated With Mitomycin C Following Femtosecond Flap Creation.
|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. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03101501|
Recruitment Status : Terminated (The manufacturing company of the Raindrop Corneal Inlay has stopped distribution or sales of the product.)
First Posted : April 5, 2017
Last Update Posted : August 13, 2019
|Condition or disease||Intervention/treatment||Phase|
|Presbyopia||Drug: Mitomycin c Device: Raindrop Near Vision Inlay||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||9 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Prospective Study To Evaluate The Raindrop Near Vision Inlay In Presybopic or Pseudophakic Patients Treated With Mitomycin C Following Femtosecond Flap Creation.|
|Actual Study Start Date :||February 14, 2017|
|Actual Primary Completion Date :||February 1, 2018|
|Actual Study Completion Date :||February 1, 2018|
- Drug: Mitomycin c
Low dose mitomycin C at a concentration of 0.02% will be applied a duration of 10 to 30 seconds at the time of the surgical procedure.
- Device: Raindrop Near Vision Inlay
Implanted to improve near vision in Presbyopic or Pseudophakic subjects.
- Uncorrected Visual Acuity [ Time Frame: 24 months ]After the inlay procedure, patients will attain functional near visual acuity in the inlay eye and functional distance acuity binocularly.
- Incidence of Corneal Reaction [ Time Frame: 24 months ]Patients treated with low dose mitomycin C will have minimal levels of corneal reaction.
- Endothelial Cell Count (measured by Konan Specular Microscope) [ Time Frame: 24 months ]Patients treated with low dose mitomycin C will not lose more than 10% of their endothelial cell count from the preoperative measurement
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): NCT03101501
|United States, Minnesota|
|Chu Vision Institue|
|Bloomington, Minnesota, United States, 55420|
|United States, Texas|
|Key-Whitman Eye Center|
|Dallas, Texas, United States, 75243|
|San Antonio, Texas, United States, 78229|
|Principal Investigator:||Jeffrey Whitman, M.D.||Key-Whitman Eye Center|