- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03376412
A Study to Evaluate the Raindrop Near Vision Inlay Under Flap or Within Pocket
A Prospective Study to Evaluate the Raindrop Near Vision Inlay in Presbyopes Implanted Under a Corneal Flap or Within a Small-Incision Pocket
Study Overview
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Phase 4
Contacts and Locations
Study Contact
- Name: Shilpa D. Rose, MD
- Phone Number: (301) 461-4372
- Email: shilpadrose@gmail.com
Study Locations
-
-
District of Columbia
-
Washington, District of Columbia, United States, 20016
- Recruiting
- Whitten Laser Eye
-
Contact:
- Shilpa D Rose, MD
- Phone Number: 301-461-4372
- Email: shilpadrose@gmail.com
-
Principal Investigator:
- Shilpa D Rose, MD
-
Principal Investigator:
- Mark E Whitten, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
1.1.1 Patients require a near reading add from +1.5 to +2.5 D in the non-dominant eye.
1.1.2 Patients have a photopic pupil size of at least 3.0 mm in the non-dominant eye.
1.1.3 Patients have a central corneal thickness ≥ 500 microns in the non-dominant eye.
1.1.4 Patients have corrected distance and near visual acuity of 20/25 or better in each eye.
1.1.5 Patients have uncorrected near acuity of 20/40 or worse in the non-dominant eye.
1.1.6 Patients are willing and able to understand and sign a written Informed Consent Form prior to any study-specific procedures.
1.1.7 Patients are willing and able to return for scheduled follow-up examinations for 24 months after corneal inlay implantation.
Exclusion Criteria:
1.1.1 Patients with clinically significant dry eye (i.e., significant diffuse punctate staining with fluorescein and a tear breakup time less than 8 s) in either eye.
1.1.2 Patients with a planned corneal residual bed thickness that is less than 250 microns (corneal thickness - (intended flap thickness + intended ablation depth)).
1.1.3 Patients with macular pathology based on dilated fundus exam and/or optical coherence tomography (OCT) image.
1.1.4 Patients who would be co-managed by an ophthalmologist or optometrist who is not approved as a ReVision Optics investigator.
1.1.5 Patients with ocular pathology or disease (including pupil pathology such as fixed pupils) that might confound the outcome or increase the risk of adverse event.
1.1.6 Patients taking systemic or topical medications that might confound the outcome or increase the risk of adverse event. Patients taking isotretinoin or amiodarone hydrochloride and any other medication that affects the tear film or accommodation, including but not limited to, mydriatic, cycloplegic and mitotic agents, tricyclic, phenothiazines, benzodiazepines, and first generation antihistamines.
1.1.7 Patients with known sensitivity to any planned study medications. 1.1.8 Patients with residual, recurrent, active or uncontrolled eyelid disease. 1.1.9 Patients with significant corneal asymmetry or irregular topography. 1.1.10 Patients with clinically significant anterior segment pathology. 1.1.11 Patients with any corneal abnormality, including but not limited to, slit lamp findings for corneal staining Grade 3 or higher, recurrent corneal erosion or severe basement membrane disease, and pterygium extending onto the cornea.
1.1.12 Patients with ophthalmoscopic/topographic signs of keratoconus or those who are keratoconus suspect.
1.1.13 Patients with history of Herpes zoster or Herpes simplex keratitis. 1.1.14 Patients with any progressive retinal disease or patients with a history or evidence of retinal vascular occlusion and/or hypercoagulability, because of the risks associated with high pressures during suction application.
1.1.15 Patients with known history of steroid-responsive intraocular pressure increases, glaucoma, preoperative IOP > 21 mm Hg, or are otherwise suspected of having glaucoma.
1.1.16 Patients with amblyopia or strabismus or those who are at risk for developing strabismus postoperatively as determined by corneal light reflex and cover-uncover testing.
1.1.17 Patients with diabetic retinopathy, collagen, vascular, diagnosed autoimmune disease (e.g., lupus, rheumatoid arthritis, fibromylagia), immunodeficiency (e.g., HIV), connective tissue disease, or clinically significant atopic syndrome such as allergies or asthma.
1.1.18 Patients on chronic systemic corticosteroid or other immunosuppressive therapy that may affect wound healing.
1.1.19 Patients with any type of active cancer (ophthalmic or non-ophthalmic). 1.1.20 Patients with uncontrolled infections of any kind. 1.1.21 Patients who are pregnant, lactating, of child-bearing potential and not practicing a medically approved method of birth control, or planning to become pregnant during the course of the trial, and patients with other conditions associated with fluctuation of hormones that could lead to refractive changes.
1.1.22 Patients who actively participate in contact sports (i.e., boxing, martial arts) where impacts to the face and eye are a normal occurrence.
1.1.23 Patients participating in any other ophthalmic or non-ophthalmic drug/device clinical trials during the time of this clinical investigation.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Single Arm Treatment.
All patients will be unilaterally implanted in the non-dominant eye with the Raindrop Near Vision Inlay for the compensation of presbyopia.
|
A maximum of 60 consecutive non-dominant eyes will be implanted with the Raindrop Near Vision Inlay.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Uncorrected Visual Acuity
Time Frame: 24 Months
|
After the inlay procedure, patients will attain functional near acuity in the inlay eye and functional distance vision binocularly.
|
24 Months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of Corneal Reaction
Time Frame: 24 Months
|
Patients implanted either under a corneal flap or within a small-incision pocket will have minimal incidence of corneal reaction.
|
24 Months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Mark E. Whitten, MD, Whitten Laser Eye
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SDR2017-004
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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