A Study Raindrop Near Vision Inlay in Presbyopes Implanted in Corneal Pockets

NCT03326869 | Terminated Results FDA Device

• 1 other identifier: ECNF17-001
• Study Type: interventional
• Target: 2
• 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 in corneal pockets with a delayed or a non-delayed approach.

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 (2)

Delayed

EXPERIMENTAL

Intervention: Raindrop Near Vision Inlay In the delayed approach, the corneal pocket is created and dissected but the corneal inlay is not implanted. After one to three months, the corneal inlay is implanted on a second surgical day.

Device: Raindrop Near Vision Inlay

Non-Delayed

ACTIVE COMPARATOR

Intervention: Raindrop Near Vision Inlay In the non-delayed approach, the corneal pocket is created and inlay implanted on the same surgical day.

Device: Raindrop Near Vision Inlay

Interventions

Raindrop Near Vision Inlay DEVICE

The Raindrop Near Vision Inlay was approved by the US FDA in June of 2016 for the improvement of near vision in presbyopic emmetropes. Raindrop is a clear device made of a hydrogel material and resembles a microscopic contact lens; it is the first implantable device that changes the shape of the cornea to correct the refractive errors that cause near vision problems.

Delayed; Non-Delayed

Eligibility Criteria

• Age: 41 Years - 65 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 300 microns (corneal thickness - (intended ablation depth + intended flap thickness)).
• 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 fixated 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

• Eye Center of North Florida: lead

Study Sites (1)

Eye Center of North Florida

Panama City, Florida, 32409, United States

Location

MeSH Terms

Conditions

Presbyopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Limitations and Caveats

Study data has been lost to natural disaster (Hurricane Micheal), therefore there is no study data that is available to report

Results Point of Contact

• Title: Christina Menck
• Organization: Eye Center of N Florida

eyenerdgyrl1@gmail.com

8507843937

Study Officials

• Bret L. Fisher, MD

  Eye Center of North Florida

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: No Masking.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The study will be a prospective, multicenter, open label clinical trial where a maximum of 30 non-dominant eyes are implanted with the Raindrop Near Vision Inlay. Each surgical site will be responsible for assigning patients to either the delayed or the non-delayed groupings.

Study Record Dates

• First Submitted: October 27, 2017
• First Posted: October 31, 2017
• Study Start: October 18, 2017
• Primary Completion: October 23, 2018
• Study Completion: October 23, 2018
• Last Updated: August 10, 2020
• Results First Posted: August 10, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)