TerminatedNCT03017612Updated Mar 1, 2018Results posted

A Clinical Trial to Evaluate the Safety and Effectiveness of the Raindrop Near Vision Inlay for Pseudophakic Subjects

An interventional study of Raindrop Near Vision Inlay in Presbyopia, sponsored by ReVision Optics, Inc.. Terminated at 6 sites in United States. Per ClinicalTrials.gov, last updated 2018-03-01.

Sponsored by ReVision Optics, Inc. · Not applicable, Interventional, and Treatment

Why this study was terminated

Change of inlay from no bevel to bevel design

Phase: Not applicable
Study type: Interventional
Enrollment: 13
Allocation: Not applicable
Sex: All

Study summary

The objective of this study is to evaluate the safety and effectiveness of the Raindrop Near Vision Inlay implanted in bilateral pseudophakes with presbyopia for improvement of near and intermediate vision. The ReVision Optics corneal inlay is a 2.0-mm, 30-micron inlay made of a hydrogel material, implanted under a lasik flap. Subjects must require reading add from +1.50 D to +2.50 D. Subjects must have a preoperative manifest refraction spherical equivalent of -0.50 to +1.00 D with no more than 0.75 D of refractive cylinder. The Raindrop Near Vision Inlay will be implanted in the non-dominant eye.

Read the detailed description

Presbyopia is a natural outcome of pseudophakic subjects with monofocal or toric intraocular lenses. Treatment of pseudophakic presbyopia generally consists of reading glasses, contact lenses, or monovision LASIK, which allows the patient to see near objects. All these options suffer limitations from the patient perspective. For example, reading glasses can easily be lost or not conveniently available. Multifocal contact lenses suffer from visual symptoms and instability due to potential rotation and movement of the contact lenses on the surface of the cornea. And, successful monovision is generally limited to patients with a history of successful use of contact lenses for monovision, and even in these eyes, monovision is associated with a substantial decrease in stereo acuity and contrast sensitivity.

ReVision Optics has developed the Raindrop Near Vision Inlay for the correction of near and intermediate vision. 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 Near Vision Inlay is expected to provide low induction of visual symptoms and improvement of near and intermediate vision in emmetropic subjects with presbyopia. This technology may also demonstrate potential clinical utility in bilateral pseudophakic subjects.

Conditions studied

Presbyopia

Browse trials for

Presbyopia 336

Keywords

Presbyopia

In context

Presbyopia

336 studies on the registry are indexed under Presbyopia; 35 are open to participants now.

This study's enrollment of 13 is below the median of 61 across 276 interventional studies indexed under Presbyopia.

Browse Presbyopia studies →

Lead sponsor

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.

Who can participate

Ages eligible: Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible: All
Accepts healthy volunteers: No

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Inclusion criteria

Subjects must provide , have signed the written informed consent form, and been given a copy.
Subjects must be bilateral pseudophakic adults with presbyopia, needing reading add from +1.50 D to +2.50 D.
Subjects must have uncorrected near visual acuity worse than 20/40 and better than 20/200 in the non-dominant eye.
Subjects must have an uncorrected distance visual acuity of 20/25 or better in both eyes.
Subjects must have distance and near visual acuity correctable to at least 20/20 in both eyes.
Subjects must have a manifest refraction spherical equivalent (MRSE) between - 0.50 and +1.00 D with no more than 0.75 D of refractive cylinder in the non- dominant eye.
Subjects must have a tear break-up time (TBUT) of ≥8 seconds.
Subjects must have a central corneal thickness of between 500 and 600 microns in the non-dominant eye.
Subjects must have an average corneal power of ≥ 41.00 D and ≤ 47.00 D in the non-dominant eye.
Subjects must have a photopic pupil size of ≥3.0 mm, in the non-dominant eye.
Subjects must have an estimated endothelial cell count of ≥ 2000 cells/mm2 in the non-dominant eye.
Subjects must be willing and able to return for scheduled follow-up examinations for 24 months after surgery.
Subjects must have documented monovision tolerance.
Subjects must have a minimum of 3 months between cataract surgery and implantation of the Raindrop Near Vision Inlay in the non-dominant eye.
Subjects must be able to demonstrate refractive stability after cataract surgery (e.g. No change in MRSE greater than ± 0.50 D within the last 2 consecutive visits at least 2 months apart) in the non-dominant eye.
Subjects must have a clear or open posterior capsule in the non-dominant eye. -

Exclusion criteria

Exclusion Criteria:

1. Subjects with anterior chamber IOLs, or posterior chamber, accommodating, or multifocal intraocular lenses (IOLs) in either eye.
  1. Subjects with anterior segment pathology in either eye.
  1. Subjects who have worn soft or rigid contact lenses within the past 30 days in the eye to be treated.
  1. Subjects with residual, recurrent, active ocular or uncontrolled eyelid disease (e.g., meibomian gland dysfunction), or any corneal abnormality (including endothelial dystrophy, guttata, recurrent corneal erosion, etc.) in either eye.
  1. Subjects with ophthalmoscopic signs of keratoconus (or keratoconus suspect) in either eye.
  1. Subjects with distorted or unclear corneal mires on topography maps of the non- dominant eye.
  1. Subjects who require canthotomy to generate a corneal flap in the non-dominant eye.
  1. Subjects with macular degeneration, retinal detachment, or any other fundus pathology that would prevent an acceptable visual outcome in either eye.
  1. Subjects who have undergone previous corneal surgery including LASIK surgery in the non-dominant eye.
  1. Subjects with a history of herpes zoster or herpes simplex keratitis.
  1. Subjects who have a history of -responsive rise in intraocular pressure, preoperative IOP > 21 mm Hg, glaucoma, or are a glaucoma suspect in either eye.
  1. Subjects with a history of uncontrolled diabetes, disease connective tissue disease, or atopic syndrome.
  1. Subjects on chronic systemic corticosteroids or other therapy that may affect wound healing, and any immunocompromised subjects.
  1. Subjects who are using ophthalmic medication(s) other than artificial tears for treatment of any ocular pathology excluding ocular allergy.
  1. Subjects using systemic medications with significant ocular side effects.
  1. Subjects with known sensitivity to planned study concomitant medications.
  1. Subjects who are participating in any other clinical trial during the course of this clinical investigation.

Terms in these criteria, in plain language(5)

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.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

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.

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.

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.

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.

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Study design

Phase: Not applicable
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrollment: 13 participants (actual)

Study arms

Experimental
Single Arm Study
Evaluating the safety and effectiveness of the raindrop near vision inlay implanted in bilateral pseudophakic subjects
Device: Raindrop Near Vision Inlay

Interventions

DeviceRaindrop Near Vision Inlay
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 and intermediate vision.

What researchers measure

Primary outcomes

Percentage of Implanted Eyes With Improvement in Uncorrected Near Vision
75% of implanted eyes should achieve uncorrected near visual acuity (40cm/16in) of 20/40 or better
Time frame: 12 months postoperatively

Secondary outcomes

Preservation of Best Corrected Visual Acuity
Fewer than 5% of eyes should lose two lines or more of best corrected distance and near visual acuity and less than 1% of eyes with preoperative best corrected visual acuity (BCVA) of 20/20 should have best corrected distance and near visual acuity worse than 20/40
Time frame: at 6 months postoperatively and all subsequent time points up to 24 months
Percentage of Implanted Eyes With a Postoperative Manifest Refraction Astigmatism That Increased From Baseline by Greater Than 2.00 D
Fewer than 5% of eyes should have postoperative manifest refractive astigmatism that increases from baseline by greater than 2.00 D
Time frame: At 6 months postoperatively and all subsequent time points up to 24 months
Occurrence of Adverse Events
Any specific adverse event should occur in less than or equal to 5% of eyes.
Time frame: During the length of the study, up to 24 months
Uncorrected Intermediate Visual Acuity
75% of eyes should achieve uncorrected intermediate visual acuity (80 cm/32 in) of 20/40 or better
Time frame: at 12 months postoperatively

Results

Posted Mar 1, 2018

Limitations and caveats

Early termination leading to small numbers of subjects analyzed.

Participant flow

Participant flow — Overall Study
Milestone	Single Arm Study
Started	13
Completed	11
Not completed	2
Withdrew: Adverse event	2

Outcome measures

PrimaryPercentage of Implanted Eyes With Improvement in Uncorrected Near Vision

75% of implanted eyes should achieve uncorrected near visual acuity (40cm/16in) of 20/40 or better

Time frame:: 12 months postoperatively
Reported as:: Number · Percentage of Implanted Eyes

Percentage of Implanted Eyes With Improvement in Uncorrected Near Vision
Percentage of Implanted Eyes	Single Arm Study
Percentage of Implanted Eyes With Improvement in Uncorrected Near Vision	100

SecondaryPreservation of Best Corrected Visual Acuity

Fewer than 5% of eyes should lose two lines or more of best corrected distance and near visual acuity and less than 1% of eyes with preoperative best corrected visual acuity (BCVA) of 20/20 should have best corrected distance and near visual acuity worse than 20/40

Time frame:: at 6 months postoperatively and all subsequent time points up to 24 months
Reported as:: Number · Percentage of Implanted Eyes

Preservation of Best Corrected Visual Acuity
Percentage of Implanted Eyes	Single Arm Study
Preservation of Best Corrected Visual Acuity	92

SecondaryPercentage of Implanted Eyes With a Postoperative Manifest Refraction Astigmatism That Increased From Baseline by Greater Than 2.00 D

Fewer than 5% of eyes should have postoperative manifest refractive astigmatism that increases from baseline by greater than 2.00 D

Time frame:: At 6 months postoperatively and all subsequent time points up to 24 months
Reported as:: Number · Percentage of Implanted Eyes

Percentage of Implanted Eyes With a Postoperative Manifest Refraction Astigmatism That Increased From Baseline by Greater Than 2.00 D
Percentage of Implanted Eyes	Single Arm Study
Percentage of Implanted Eyes With a Postoperative Manifest Refraction Astigmatism That Increased From Baseline by Greater Than 2.00 D	0

SecondaryOccurrence of Adverse Events

Any specific adverse event should occur in less than or equal to 5% of eyes.

Time frame:: During the length of the study, up to 24 months
Reported as:: Number · Occurrence of specific adverse events

Occurrence of Adverse Events
Occurrence of specific adverse events	Single Arm Study
Intraocular Pressure increase	2
Inlay Explant	2
Diffuse Lamellar Keratitis	1
Loss of BCVA due to late onset of haze	1
Hospitalization	1
Epiretinal Membrane	1

SecondaryUncorrected Intermediate Visual Acuity

75% of eyes should achieve uncorrected intermediate visual acuity (80 cm/32 in) of 20/40 or better

Time frame:: at 12 months postoperatively
Reported as:: Number · Percentage of Implanted Eyes

Uncorrected Intermediate Visual Acuity
Percentage of Implanted Eyes	Single Arm Study
Uncorrected Intermediate Visual Acuity	92

Adverse events

Collected over 1 day, 1 week, 1 month, 3 months, 6 months, 9 months, 12 months. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Single Arm Study	—	1/13 (7.7%)	5/13 (38.5%)

Most frequent serious events

Most frequent serious events
Event	Single Arm Study
Hospitalization due to triple arthrodesis surgery (secondary to muscular dystrophy)Musculoskeletal and connective tissue disorders	1/13

Most frequent other events

Most frequent other events
Event	Single Arm Study
Increase in intraocular pressure > 10mmHg above baselineEye disorders	2/13
Inlay explantEye disorders	2/13
Diffuse Lamellar Keratitis (DLK)Eye disorders	1/13
Loss of BCVA due to late onset of hazeEye disorders	1/13
Epiretinal MembraneEye disorders	1/13

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)	Single Arm Study
<=18 years	0
Between 18 and 65 years	5
>=65 years	8

Sex: Female, Male
Sex: Female, Male(Participants)	Single Arm Study
Female	7
Male	6

Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)	Single Arm Study
Caucasian	10
African American	1
Asian	0
Hispanic	2
Other	0

Region of Enrollment
Region of Enrollment(Participants)	Single Arm Study
United States	13

Study locations

6 sites

Harvard Eye Associates
Laguna Hills, California 92653, United States
Coastal Vision
Orange, California 92868, United States
Chu Vision Institute
Bloomington, Minnesota 55420, United States
Key-Whitman Eye Center
Dallas, Texas 75204, United States
Carter Eye Center
Dallas, Texas 75205, United States
Parkhurst-NuVision
San Antonio, Texas 78229, United States

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

Timeline

Tracking since Sep 25, 2026

Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Jul 2014, a primary completion of Dec 2016 and a completion of Dec 2016. It does not say whether these dates are actual or estimated.

Results were first posted in Mar 2018, 1 year 3 months after primary completion.

How these figures are worked out, and which studies are left out of them.

Registered: Feb 12, 2015
First posted: Jan 11, 2017
Start: Jul 2014
Primary completionActual: Dec 2016
CompletionActual: Dec 2016
Results first posted: Mar 1, 2018
Last update: Mar 1, 2018

What these dates mean

Start.: When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.: When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.: When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.: Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.

No changes since tracking began. The registry record was last updated on Mar 1, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT03017612
Lead sponsor: ReVision Optics, Inc.
Responsible party: Sponsor
First posted: Jan 11, 2017
Start date: Jul 2014
Primary completion: Dec 2016
Completion: Dec 2016
Results posted: Mar 1, 2018
Last update: Mar 1, 2018

Study contacts

Roger Steinert, MD

study chair · Interim Dean, School of Medicine; Irving H. Leopold Professor of Ophthalmology; University of Californa, Irvine, CA

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

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This study is terminated, as verified in Feb 2018. You cannot join it, but the record below documents what was studied.

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