An interventional study of The Raindrop Near Vision Inlay in Presbyopia, sponsored by ReVision Optics, Inc.. Completed at 11 sites in United States. Open to participants aged 35 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-03-29.
Sponsored by ReVision Optics, Inc. · Not applicable, Interventional, and Treatment
This study will be a prospective, multicenter clinical trial in which a total of 400 subjects will be enrolled. All subjects will be followed over a 36 month time frame with a maximum of 15 clinical sites participating. Qualified subjects will provide informed consent for entry into the study.
The loss of near vision and the ability to perform tasks that require near vision is part of the normal aging process. This natural transformation in the eye occurs as a result of the loss of accommodation of the crystalline lens, a condition known as presbyopia. Presbyopia, characterized by a progressive, age-related loss of accommodation (i.e., the lens ability to focus clearly over a wide range of distances), is most prevalent of all visual deficiencies, affecting 100% of the population over the course of a normal life span. Loss of accommodation begins early in life and, for an emmetropic eye, generally culminates in a complete loss of functional near vision.
ReVision Optics has developed the Raindrop corneal inlay for the correction of near vision. The Raindrop is a 2mm corneal inlay, as small as a pinhead, thinner than a human hair and about 1/500th of a droplet of water. The inlay is the same refractive index as the human cornea. The inlay is placed in the non-dominant eye,centered over the pupil after a corneal flap (LASIK)has been made. The Raindrop is expected to provide presbyopic subjects with improvement of near and intermediate vision.
336 studies on the registry are indexed under Presbyopia; 35 are open to participants now.
This study's enrollment of 373 is above the median of 61 across 276 interventional studies indexed under Presbyopia.
Browse Presbyopia studies →ReVision Optics, Inc. is the lead sponsor of 3 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
must be presbyopic adults, needing from +1.50 to +2.50 or reading add must have uncorrected near visual acuity worse than 20/40 and better than 20/200in the eye to be implanted must have an uncorrected distance visual acuity of 20/25 or better in both eyes must have a distance visual acuity correctable to 20/20 in both eyes must have a near visual acuity correctable to 20/20 in both eyes must have a manifest refraction spherical equivalent between -0.50 and +1.00D in the eye to be implanted with no more than 0.75D of refractive cylinder must report stable vision, i.e. no change in distance vision and or MRSE within 0.50D over prior 12 months must discontinue hard or rigid gas permeable lenses for at least 3 weeks and discontinue soft lenses for at least 1 week prior to baseline examination must have a minimum central corneal thickness of >500 microns in the eye to be implanted must have a mesopic pupil \< 7.0mm and photopic pupil >3.0mm in the eye to be implanted subjects aged 45 years or younger must have an endothelial cell count
Exclusion Criteria:
Subjects with a difference of >0.75 between the manifest refraction spherical equivalent and the cycloplegic refraction spherical equivalent Subjects with anterior segment pathology, including cataracts, in the non-dominant eye Subjects with residual, recurrent, active ocular or uncontrolled eyelid disease, or any corneal abnormality (including endothelial dystrophy, guttata, recurrent corneal erosion, etc.) in the non-dominant eye Subjects with ophthalmoscopic signs of keratoconus (or keratoconus suspect) in the non-dominant eye Subjects with clinically significant dry eyes, as determined by either the presence of greater than mild symptoms of dryness or discomfort or SPK greater than grade 1 Subjects with distorted or unclear mires on topography maps of the non-dominant eye Subjects with macular degeneration, retinal detachment, or any other fundus pathology that would prevent an acceptable visual outcome in the non-dominant eye Subjects who have undergone LASIK surgery in the non-dominant eye Subjects with a history of herpes zoster or herpes simplex keratitis Subjects who have a history of responsive rise in intraocular pressure, pre-operative IOP>21 mm Hg, glaucoma or are a glaucoma suspect Subjects with a history of diagnosed diabetes, disease, connective tissue disease, or clinically significant atopic syndrome Subjects on chronic systemic corticosteroids or other therapy that may affect wound healing, and any immunocompromised subjects Subjects who are using ophthalmic mediation(s) other than artificial tears for treatment of any ocular pathology Subjects using systemic medications with significant ocular side effects Subjects who are pregnant, lactating, or planning to become pregnant during the course of the study Subjects what are participating in any other ophthalmic drug or device studies during the time of this clinical investigation Subjects with known sensitivity to planned study concomitant medications
-
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A single-arm study to evaluate the effectiveness of a 2 mm corneal inlay (Raindrop Near Vision Inlay) for the treatment of presbyopia (age-related near vision loss). The anterior curvature of the cornea is re-shaped after implanting the Raindrop Near Vision Inlay in the non-dominant eye under a femtosecond laser flap to improve near vision.
Device: The Raindrop Near Vision Inlay
The Raindrop Near Vision Inlay is implanted in the cornea for treatment of presbyopia
Also known as: Presbylens
Number of Participants With Improvement in Uncorrected Near Visual Acuity (20/40 or Better) in the Implanted Eye
75% of participants should achieve uncorrected near visual acuity in the implanted eye of 20/40 or better as compared to preoperative baseline
Time frame: 24 Months
Number of Participants With no or Minimal Loss of Best Corrected Visual Acuity in the Implanted Eye
Less than 5% of participants should lose more than two lines of best corrected distance and near visual acuity in the implanted eye; and less than 1% of participants with preoperative best spectacle corrected visual acuity (BCDVA) of 20/20 in the implanted eye should have best corrected distance and near visual acuity worse than 20/40 in the implanted eye at 6 months postoperative and all subsequent visits.
Time frame: at 6 months postoperative and all subsequent visits
Number of Participants With Induced Manifest Refractive Astigmatism in the Implanted Eye
Less than 5% of participants should have postoperative manifest refractive astigmatism in the implanted eye that increases from baseline by greater than 2.00 D at 6 months postoperative and all subsequent visits.
Time frame: At 6 months postoperative and all subsequent visits
| Milestone | Raindrop |
|---|---|
| Started | 373 |
| Completed | 317 |
| Not completed | 56 |
75% of participants should achieve uncorrected near visual acuity in the implanted eye of 20/40 or better as compared to preoperative baseline
| Count of Participants | Raindrop |
|---|---|
| Number of Participants With Improvement in Uncorrected Near Visual Acuity (20/40 or Better) in the Implanted Eye | 336 |
Less than 5% of participants should lose more than two lines of best corrected distance and near visual acuity in the implanted eye; and less than 1% of participants with preoperative best spectacle corrected visual acuity (BCDVA) of 20/20 in the implanted eye should have best corrected distance and near visual acuity worse than 20/40 in the implanted eye at 6 months postoperative and all subsequent visits.
| Count of Participants | Raindrop |
|---|---|
| # of participants@6M w/loss >/= 2 lines of BCVA | 0 |
| # of participants@9M w/loss >/= 2 lines of BCVA | 1 |
| # of participants@12M w/loss >/= 2 lines of BCVA | 1 |
| # of participants@18M w/loss>/= 2 lines of BCVA | 1 |
| # of participant@24M w/loss >/= 2 lines of BCVA | 1 |
| # of participants@6M w/BCDVA or BCNVA < 20/40 | 0 |
| # of participants@9M w/BCDVA or BCNVA < 20/40 | 1 |
| # of participants@12M w/BCDVA or BCNVA < 20/40 | 0 |
| # of participants@18M w/BCDVA or BCNVA < 20/40 | 0 |
| # of participants@24M w/BCDVA or BCNVA < 20/40 | 0 |
Less than 5% of participants should have postoperative manifest refractive astigmatism in the implanted eye that increases from baseline by greater than 2.00 D at 6 months postoperative and all subsequent visits.
| Count of Participants | Raindrop |
|---|---|
| #of participants@6M w/>2D increase in astigmatism | 0 |
| #of participants@9M w/>2D increase in astigmatism | 0 |
| #of participants@12M w/>2D increase in astigmatism | 0 |
| #of participants@18M w/>2D increase in astigmatism | 0 |
| #of participants@24M w/>2D increase in astigmatism | 0 |
Collected over Day 1, Week 1, Months 1, 2, 3, 6, 9, 12, 18, 24, 30, 36. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Raindrop | 1/373 (0.3%) | 25/373 (6.7%) | 115/373 (30.8%) |
| Event | Raindrop |
|---|---|
| Hospitalization secondary to heart diseaseCardiac disorders | 10/373 |
| Hospitalization secondary to other surgerySurgical and medical procedures | 8/373 |
| Hospitalization due to adverse reaction to medicationGeneral disorders | 2/373 |
| DeathGeneral disorders | 1/373 |
| Hospitalization due to Ischemic ColitisGastrointestinal disorders | 1/373 |
| Hospitalization due to PneumoniaRespiratory, thoracic and mediastinal disorders | 1/373 |
| Hospitalization for Transient Ischemic AttackNervous system disorders | 1/373 |
| Hospitalization for elevated blood sugarBlood and lymphatic system disorders | 1/373 |
| Hospitalization for fainting/upper extremity pain - no formal diagnosisGeneral disorders | 1/373 |
| Infection secondary to achilles tendon surgeryMusculoskeletal and connective tissue disorders | 1/373 |
| Event | Raindrop |
|---|---|
| Secondary Surgical InterventionEye disorders | 54/373 |
| Loss in BCDVA of > 2 lines (11 letters or more) at 3 months or laterEye disorders | 14/373 |
| Epithelial ingrowthEye disorders | 11/373 |
| Ocular infectionEye disorders | 7/373 |
| Increase in Intraocular Pressure of greater than 10mmHg above baselineEye disorders | 7/373 |
| Diffuse Lamellar Keratitis (DLK)Eye disorders | 6/373 |
| Late onset of haze beyond 6 months with loss of 2 lines (10 letters) or more BCVAEye disorders | 4/373 |
| Anterior UveitisEye disorders | 4/373 |
| Cataract (with loss in BCDVA greater than or equal to 2 lines at any timeEye disorders | 2/373 |
| Corneal Epithelial Defect Involving the KeratectomyEye disorders | 2/373 |
| Age, Continuous(Years) | Raindrop |
|---|---|
| Mean | 51.3 ± 4.3 |
| Sex: Female, Male(Participants) | Raindrop |
|---|---|
| Female | 204 |
| Male | 169 |
| Race/Ethnicity, Customized(Participants) | Raindrop |
|---|---|
| Caucasian | 290 |
| African American | 10 |
| Asian | 6 |
| Hispanic | 52 |
| Other | 15 |
| Region of Enrollment(Participants) | Raindrop |
|---|---|
| United States | 373 |
Plan to share: No
This study is completed, as verified in Mar 2018. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
ReVision Optics, Inc.