A Prospective Study to Evaluate the Raindrop Near Vision Inlay in Presbyopic Patients With Treatments to Optimize the Ocular Surface Before Implantation

NCT03126877 | Unknown Phase 4 FDA Drug FDA Device

• 1 other identifier: R2017-001
• Study Type: interventional
• Target: 40
• 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 presbyopic patients with treatments to optimize the ocular surface before corneal inlay surgery.

Conditions

Presbyopia

Outcome Measures

Primary Outcomes (1)

• Uncorrected Visual Acuity

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

  24 Months

Secondary Outcomes (2)

• Incidence of Corneal Reaction

  24 Months

• Ocular Surface Health (Preoperative Optimization)

  24 Months

Study Arms (2)

Optimized Ocular Surface

EXPERIMENTAL

For patients enrolled into the treatment group for preoperative optimization of the ocular surface, utilize the LipiFlow® vectored thermal pulsating eyepieces (Activators) to gently apply heat and massage, thus evacuating the Meibomian glands. Omega-3 vitamin supplements should also be provided, initiated and dosed according to standard clinical practice, to maximize ocular surface health.

Drug: Mitomycin C; Device: Raindrop Near Vision Inlay

Non-Optimized Ocular Surface

ACTIVE COMPARATOR

Patients enrolled into the non-treatment group will not be optimized preoperatively for ocular surface health. No LipiFlow® Activators and no Omega-3 vitamin supplements will be provided, initiated, nor dosed.

Drug: Mitomycin C; Device: Raindrop Near Vision Inlay

Interventions

Mitomycin C DRUG

The surgical procedure includes a low dose, short duration mitomycin C (MMC) treatment on the exposed stromal bed of the non-dominant eye, before the unilateral implantation of the corneal inlay. This treatment is at a concentration of 0.2 mg/mL (0.02%) applied for 10 to 30 seconds on the stromal bed as well as the stromal side of the corneal flap or pocket.

Non-Optimized Ocular Surface; Optimized Ocular Surface

Raindrop Near Vision Inlay DEVICE

The surgical procedure includes the unilateral implantation of the Raindrop Near Vision Inlay in the non-dominante eye for the improvement of uncorrected near vision.

Non-Optimized Ocular Surface; Optimized Ocular Surface

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 corneal thickness greater than or equal to 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 distance corrected near visual acuity of 20/40 or worse in each eye.
• Patients are willing and able to sign and understand 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 the corneal inlay surgery.

You may not qualify if:

• Patients with prior ocular surgery. 1.2.2 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 has not been trained by ReVision Optics.
• 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. 1.2.9 Patients with residual, recurrent, active or uncontrolled eyelid disease. 1.2.10 Patients with significant corneal asymmetry or irregular topography. 1.2.11 Patients with clinically significant anterior segment pathology. 1.2.12 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. 1.2.15 Patients with any progressive retinal disease or subjects 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). 1.2.21 Patients with uncontrolled infections of any kind. 1.2.22 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

Interventions

Mitomycin

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Intervention Hierarchy (Ancestors)

Mitomycins; Indolequinones; Quinones; Organic Chemicals; Azirines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Shilpa D Rose, 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: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The study will be a prospective, single-center open label clinical trial where a maximum of 40 (20 with optimized ocular surface and 20 without) consecutive non-dominant eyes are implanted with the Raindrop Near Vision Inlay.

Study Record Dates

• First Submitted: April 18, 2017
• First Posted: April 25, 2017
• Study Start: April 10, 2017
• Primary Completion: September 1, 2020
• Study Completion: December 1, 2020
• Last Updated: July 14, 2017

Record last verified: 2017-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)