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

• ClinicalTrials.gov Identifier: NCT03376412
• Recruitment Status: Recruiting
• First Posted: December 18, 2017
• Last Update Posted: December 18, 2017
• Sponsor: Whitten Laser Eye
• Information provided by (Responsible Party): Whitten Laser Eye

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Presbyopia	Device: Raindrop Near Vision Inlay	Phase 4

Detailed Description:

Patients must require a reading add from +1.5 to +2.5 D, and both emmetropes as well as ametropes (requiring concurrent LASIK) are included in the investigation. Suitable patients will undergo implantation of the Raindrop inlay in the non-dominant eye to improve near vision. If necessary, a LASIK excimer ablation will first be performed to optimize postoperative vision at near and distance. Patients will follow a one-month regimen of strong steroid, at a minimum, after corneal inlay implantation to facilitate healing and visual recovery.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 60 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: 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.
• Masking: None (Open Label)
• Masking Description: No Masking.
• Primary Purpose: Treatment
• Official Title: A Prospective Study to Evaluate the Raindrop Near Vision Inlay in Presbyopes Implanted Under a Corneal Flap or Within a Small-Incision Pocket
• Actual Study Start Date: December 8, 2017
• Estimated Primary Completion Date: December 2020
• Estimated Study Completion Date: December 2020

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. 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.

Secondary Outcome Measures :

1. 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.

Eligibility Criteria

• Ages Eligible for Study: 40 Years to 70 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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.

Contacts and Locations

Contacts

Contact: Shilpa D. Rose, MD; (301) 461-4372; shilpadrose@gmail.com

Locations

United States, District of Columbia

Whitten Laser Eye; Recruiting

Washington, District of Columbia, United States, 20016

Contact: Shilpa D Rose, MD 301-461-4372 shilpadrose@gmail.com

Principal Investigator: Shilpa D Rose, MD

Principal Investigator: Mark E Whitten, MD

Sponsors and Collaborators

Whitten Laser Eye

Investigators

• Principal Investigator: Mark E. Whitten, MD; Whitten Laser Eye

More Information

• Responsible Party: Whitten Laser Eye
• ClinicalTrials.gov Identifier: NCT03376412
• Other Study ID Numbers: SDR2017-004
• First Posted: December 18, 2017
• Last Update Posted: December 18, 2017
• Last Verified: December 2017

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: Yes

Additional relevant MeSH terms:

Presbyopia; Refractive Errors; Eye Diseases