A Prospective Study to Evaluate the Raindrop Near Vision Inlay With Mitomycin C
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|ClinicalTrials.gov Identifier: NCT03242317|
Recruitment Status : Recruiting
First Posted : August 8, 2017
Last Update Posted : August 8, 2017
|Condition or disease||Intervention/treatment||Phase|
|Presbyopia||Drug: Mitomycin C Device: Raindrop Near Vision Inlay||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Prospective Study to Evaluate the Raindrop Near Vision Inlay in Presbyopes Treated With Mitomycin C During Surgery and Extended Steroid After Surgery|
|Actual Study Start Date :||June 16, 2017|
|Estimated Primary Completion Date :||September 1, 2020|
|Estimated Study Completion Date :||December 1, 2020|
Experimental: Mitomycin C + Raindrop Near Vision Inlay
The surgical procedure includes a low dose, short duration MMC treatment on the exposed stromal bed of the non-dominant eye, before the unilateral implantation of the Raindrop Near Vision Inlay in Presbyopes.
Drug: Mitomycin C
The surgical procedure includes a low dose, short duration MMC treatment on the exposed stromal bed of the non-dominant eye, before the unilateral implantation of the corneal inlay. This treatment is at a concentration of 0.2 mg/mL (0.02%) applied for 10 to 30 seconds on the stromal bed as well as the stromal side of the corneal flap or pocket.
Device: Raindrop Near Vision Inlay
The surgical procedure includes the unilateral implantation of the Raindrop Near Vision Inlay in the non-dominant eye for the improvement of uncorrected near vision.
- 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, short duration MMC intraoperatively, then an extended low dose steroid regimen will have minimal levels 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): NCT03242317
|Contact: Michael J Endl, MD||(716) email@example.com|
|United States, New York|
|Fichte Endl & Elmer Eyecare||Recruiting|
|Amherst, New York, United States, 14228|
|Contact: Micheal J Endl, MD 716-564-2020 firstname.lastname@example.org|
|Principal Investigator:||Michael J Endl, MD||Fichte, Endl & Elmer Eyecare|