Clinical trial NCT03376412: A Study to Evaluate the Raindrop Near Vision Inlay Under Flap or Within Pocket
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Presbyopia
Lead sponsor: Whitten Laser Eye
Sponsor class: OTHER
First posted: 2017-12-18
Enrollment: 60
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
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.
Primary purpose: TREATMENT

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.

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.

Eligibility 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.

Primary outcomes:
measure: Uncorrected Visual Acuity
timeFrame: 24 Months
Secondary outcomes:
measure: Incidence of Corneal Reaction
timeFrame: 24 Months
Other outcomes:
Locations:
city: Washington
country: United States
facility: Whitten Laser Eye
state: District of Columbia
Study officials:
affiliation: Whitten Laser Eye
name: Mark E. Whitten, MD
role: PRINCIPAL_INVESTIGATOR
References: