Trials / Unknown
UnknownNCT03126877
A Prospective Study to Evaluate the Raindrop Near Vision Inlay in Presbyopic Patients With Treatments to Optimize the Ocular Surface Before Implantation
- Status
- Unknown
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 40 (estimated)
- Sponsor
- Whitten Laser Eye · Academic / Other
- Sex
- All
- Age
- 41 Years – 65 Years
- Healthy volunteers
- Not accepted
Summary
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.
Detailed description
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Mitomycin C | 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. |
| DEVICE | Raindrop Near Vision Inlay | The surgical procedure includes the unilateral implantation of the Raindrop Near Vision Inlay in the non-dominante eye for the improvement of uncorrected near vision. |
Timeline
- Start date
- 2017-04-10
- Primary completion
- 2020-09-01
- Completion
- 2020-12-01
- First posted
- 2017-04-25
- Last updated
- 2017-07-14
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03126877. Inclusion in this directory is not an endorsement.