Presbyopia Clinical Trial
Official title:
A Prospective Study to Evaluate the Raindrop Near Vision Inlay in Presbyopic Patients With Treatments to Optimize the Ocular Surface Before Implantation
The objective of this study is to evaluate the Raindrop® Near Vision Inlay for the improvement of near vision in presbyopic patients with treatments to optimize the ocular surface before corneal inlay surgery.
The surgical procedure includes a low dose, short duration mitomycin C (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. In the third month after surgical procedure, a one-drop a day of low dose steroid (initiated in the second month postoperative) will be continued for the duration of the 24-month follow-up period to maintain corneal health. Only a portion of patients will receive treatments to optimize the ocular surface preoperatively, and their clinical outcomes will be statistically compared against the portion not receiving the preoperative optimization. ;
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