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

  • STATUS
    Recruiting
  • participants needed
    60
  • sponsor
    Whitten Laser Eye
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Updated on 8 November 2020
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Investigator
Shilpa D Rose, MD
Primary Contact
Whitten Laser Eye (8.2 mi away) Contact
myopia
ocular disease

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.

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.

Details
Treatment Raindrop Near Vision Inlay
Clinical Study IdentifierNCT03376412
SponsorWhitten Laser Eye
Last Modified on8 November 2020

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Eligibility

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Inclusion Criteria

Is your age between 40 yrs and 70 yrs?
Gender: Male or Female
Do you have Presbyopia?
1.1 Patients require a near reading add from +1.5 to +2.5 D in the non-
dominant eye
1.2 Patients have a photopic pupil size of at least 3.0 mm in the non-
dominant eye
1.3 Patients have a central corneal thickness 500 microns in the non-
dominant eye
1.4 Patients have corrected distance and near visual acuity of 20/25 or
better in each eye
1.5 Patients have uncorrected near acuity of 20/40 or worse in the non-
dominant eye
1.6 Patients are willing and able to understand and sign a written Informed
Consent Form prior to any study-specific procedures
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 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
1.2 Patients with a planned corneal residual bed thickness that is less than
microns (corneal thickness - (intended flap thickness + intended ablation
depth))
1.3 Patients with macular pathology based on dilated fundus exam and/or
optical coherence tomography (OCT) image
1.4 Patients who would be co-managed by an ophthalmologist or optometrist
who is not approved as a ReVision Optics investigator
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
1.6 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
1.7 Patients with known sensitivity to any planned study medications. 1.1.8
Patients with residual, recurrent, active or uncontrolled eyelid disease
1.9 Patients with significant corneal asymmetry or irregular topography
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
1.12 Patients with ophthalmoscopic/topographic signs of keratoconus or those
who are keratoconus suspect
1.13 Patients with history of Herpes zoster or Herpes simplex keratitis
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
1.15 Patients with known history of steroid-responsive intraocular pressure
increases, glaucoma, preoperative IOP > 21 mm Hg, or are otherwise suspected
of having glaucoma
1.16 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
1.17 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
1.18 Patients on chronic systemic corticosteroid or other immunosuppressive
therapy that may affect wound healing
1.19 Patients with any type of active cancer (ophthalmic or non-ophthalmic)
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
1.22 Patients who actively participate in contact sports (i.e., boxing
martial arts) where impacts to the face and eye are a normal occurrence
1.23 Patients participating in any other ophthalmic or non-ophthalmic
drug/device clinical trials during the time of this clinical investigation
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