The Raindrop Near Vision Inlay (ReVision Optics), the corneal inlay approved by the FDA in June 2016 to treat presbyopia, has since been implanted more than 1,400 times by more than 113 surgeons, according to the company. As an investigator in the Raindrop IDE clinical study, I’d like to share its results, and what I learned during and since the study.
In the Raindrop IDE clinical study, 373 patients were treated at 11 U.S. investigational sites.1 The goal was to have 75% of these patients reach 20/40 or better near vision in the surgery eye, without corrective lenses, by two years. The trial followed these patients for 36 months.
At 24 months, 344 were evaluated, and 87.5% reported 20/25 near vision in the nondominant eye (treated). That represents a 5-line gain from the patients’ pre-op near-vision assessments; 76.2% achieved an intermediate vision to 20/25 in the treated eye as well (a 2.5-line gain from pre-op levels).
Currently, the majority of patients (317) have outcomes assessed out to 36 months. On average, subjects gained 4.8 lines at near and 2.4 lines at intermediate in the inlay eye, although intermediate vision was not a study endpoint.
These devices do not substantially alter distance vision. While patients lost an average 1.2 lines of distance vision in the treated eye, binocular vision was unaffected, with vision outcomes of 20/20 distance, and 20/25 intermediate and near, from pre-op to 36 months.
As for the quality of life aspects, satisfaction rates were high — more than 86% of subjects were satisfied with their correction and over 99% were satisfied with their appearance at 36 months. In a subgroup of 135 patients who received the recommended treatment parameters according to the labeling, the inlay explant rate was 6.7% mostly due to dissatisfaction with visual outcomes or haze.
By 36 months, eight infections (1.9%) of the eye were reported; other adverse events were additional surgeries, at 11.8% (44 patients). These were to replace or remove the inlay and two people needed a flap lift.
IN THE REAL WORLD
Recently, haze mitigation has been promising in my practice. We are using off-label mitomycin C .02% for 10 to 15 seconds on both the stromal bed and stromal side of the flap, then we irrigate it off with 20 ccs of balanced salt solution before thoroughly drying the stromal bed. This can be done in emmetropic eyes or after off-label LASIK treatment, but prior to placement of the Raindrop inlay.
Our refractive goal after LASIK treatment is between +.25 and +.50 D. Raindrop has also been used off-label in pseudophakic eyes; a clinical pocket study for pseudophakic patients is ongoing.
GOOD MATCHMAKING IS CRITICAL
Patient selection and preoperative counseling are key for successful outcomes. During a comprehensive, pre-implantation eye exam, it is crucial to check for any eye disease, ocular surface disease, cataracts or steroid responsiveness. If a patient is not a good candidate clinically for LASIK, they are not a good candidate for Raindrop.
It is also important to choose a motivated patient to reduce the need for glasses and to make sure the appropriate expectations are set. A contact lens trial with a multifocal lens, or even mild monovision, can separate out potentially unhappy patients.
They also need to be coached on reasonable visual expectations. For example, their distance vision may still be blurry and their near vision will be focused very close for the first few days and weeks after surgery.
Postoperative management and patient education are other important pieces to success; these include instructions to avoid all types of physical contact with the eye, including wearing makeup and working in the garden. Follow-up visits — at one-day postop, one week, one month, and then twice annually — need to be scheduled.1
Patients must know that any blurred distance vision, reduced near, glare, halos, pain or ocular discomfort warrant a return visit to the clinic.1
In my experience, if these guidelines are followed, patients will experience excellent outcomes.
- Patient information brochure. ReVision Optics, Inc. https://www.accessdata.fda.gov/cdrh_docs/pdf15/P150034d.pdf Last accessed Sept. 13, 2017.
For more information on the Raindrop’s specs, visit http://www.ophthalmologymanagement.com/issues/2017/september-2017/a-roadmap-for-inlay-success .
About the Author
Monovision/modifed LASIK vs. corneal inlays
Corneal inlays offer near and intermediate vision improvements to meet the needs of the modern patient lifestyle.
By Shilpa Rose, MD, and Mark Whitten, MD
Monovision LASIK has been a staple vision correction option for presbyopes for years, but the perception of how to treat these patients has shifted with the advent of corneal inlays. In this article, we will discuss the differences between the two and provide reasons why inlays, after proper patient selection, are the better option.
NOT FOR EVERYONE
In general, monovision LASIK and monovision are not for everyone. The nondominant eye is used for near vision, and for every line of visual improvement there’s an equal trade-off in loss of distance vision lines. A decrease in balanced vision can affect stereopsis and depth perception for many.
For some patients who play tennis or golf, stereopsis becomes unacceptable. By preoperatively screening patients to gauge their participation level in these types of sports, we can determine whether they require a different solution to increase their likelihood of satisfaction.
Modified monovision, or blended vision, is another potential surgical option. But its results may not last, nor does it provide a full range of vision or depth of focus. While there is slight improvement in intermediate vision (and more so than straight monovision LASIK), the outcome is not significant enough for patients who live in an intermediate, digital world with computers, tablets and cell phones.
But perhaps the most disconcerting aspect for those patients is that their presbyopia progression doesn’t stop — they continue to lose accommodation and eventually they return to their readers. We tend to avoid recommending this option for younger presbyopes, as they will inevitably end up needing readers, or possibly an enhancement.
CORNEAL INLAYS’ ADVANTAGE
When corneal vision inlays entered the market in 2015, they represented an exciting option for presbyopic patients not satisfied with monovision. We have found in our practice that corneal vision inlays, particularly the Raindrop, serve as an excellent bridging technology for our patients between the ages of 45 and 65.
We have found that we can simulate what patients’ vision will be like after surgery with a multifocal contact lens trial in the non-dominant eye. We counsel them at length about their expectations immediately after sugery and in the months following; they understand that their vision is likely to continue to improve for up to three months after surgery. However, during this period, we have found that patients neuro adapt and use both eyes together much better than with traditional monovision.
With inlays, visual recovery is quick; patients drive themselves to their postop day-one visit and return to work that same day. As long as the expecations are set in advance, patients with the Raindrop near vision inlay will do well with binocular balance vision and can truly enjoy depth of focus. Those with active lifestyles, including sports such as golf and tennis, do better than traditional monovision.
Decreasing or eliminating the need for readers is very appealing and exciting for the presbyopic population.
We have previously discussed and still advocate that the success of monovision is heavily weighted on patient selection, as well as their expectations. In our experience, those with near addition of less than and around +1.50 D can adapt to monovision. But this can take time, and some patients will continue to complain about a compromise in balanced binocular vision.
By offering additive procedures like inlays, patients can take full advantage of improvements in intermediate, near and distance vision without sacrificing balanced vision. Further, we can offer them a safe, long-term option for presbyopia. OM