A Study to Evaluate the Raindrop Near Vision Inlay Under Flap or Within Pocket

NCT03376412 | Unknown Phase 4 FDA Device

• 1 other identifier: SDR2017-004
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this study is to evaluate the Raindrop® Near Vision Inlay for the improvement of near vision in presbyopes implanted under a corneal flap or within a small-incision pocket.

Conditions

Presbyopia

Outcome Measures

Primary Outcomes (1)

• Uncorrected Visual Acuity

  After the inlay procedure, patients will attain functional near acuity in the inlay eye and functional distance vision binocularly.

  24 Months

Secondary Outcomes (1)

• Incidence of Corneal Reaction

  24 Months

Study Arms (1)

Single Arm Treatment.

EXPERIMENTAL

All patients will be unilaterally implanted in the non-dominant eye with the Raindrop Near Vision Inlay for the compensation of presbyopia.

Device: Raindrop Near Vision Inlay

Interventions

Raindrop Near Vision Inlay DEVICE

A maximum of 60 consecutive non-dominant eyes will be implanted with the Raindrop Near Vision Inlay.

Single Arm Treatment.

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients require a near reading add from +1.5 to +2.5 D in the non-dominant eye.
• Patients have a photopic pupil size of at least 3.0 mm in the non-dominant eye.
• Patients have a central corneal thickness ≥ 500 microns in the non-dominant eye.
• Patients have corrected distance and near visual acuity of 20/25 or better in each eye.
• Patients have uncorrected near acuity of 20/40 or worse in the non-dominant eye.
• Patients are willing and able to understand and sign a written Informed Consent Form prior to any study-specific procedures.
• Patients are willing and able to return for scheduled follow-up examinations for 24 months after corneal inlay implantation.

You may not qualify if:

• 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.
• Patients with a planned corneal residual bed thickness that is less than 250 microns (corneal thickness - (intended flap thickness + intended ablation depth)).
• Patients with macular pathology based on dilated fundus exam and/or optical coherence tomography (OCT) image.
• Patients who would be co-managed by an ophthalmologist or optometrist who is not approved as a ReVision Optics investigator.
• 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.
• 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.
• 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.
• Patients with ophthalmoscopic/topographic signs of keratoconus or those who are keratoconus suspect.
• 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.
• Patients with known history of steroid-responsive intraocular pressure increases, glaucoma, preoperative IOP \> 21 mm Hg, or are otherwise suspected of having glaucoma.
• 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.
• 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.
• Patients on chronic systemic corticosteroid or other immunosuppressive therapy that may affect wound healing.
• 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.
• Patients who actively participate in contact sports (i.e., boxing, martial arts) where impacts to the face and eye are a normal occurrence.

Sponsors & Collaborators

• Whitten Laser Eye: lead

Study Sites (1)

Whitten Laser Eye

Washington D.C., District of Columbia, 20016, United States

RECRUITING

MeSH Terms

Conditions

Presbyopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Study Officials

• Mark E. Whitten, MD

  Whitten Laser Eye

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shilpa D. Rose, MD

CONTACT

(301) 461-4372; shilpadrose@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Masking Details: No Masking.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The study will be a prospective, single-center, open label clinical trial where a maximum of 60 consecutive non-dominant eyes are implanted with the Raindrop Near Vision Inlay.

Study Record Dates

• First Submitted: December 13, 2017
• First Posted: December 18, 2017
• Study Start: December 8, 2017
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2020
• Last Updated: December 18, 2017

Record last verified: 2017-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)