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A Prospective Study To Evaluate The Raindrop Near Vision Inlay In Presybopic or Pseudophakic Patients Treated With Mitomycin C Following Femtosecond Flap Creation.

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ClinicalTrials.gov Identifier: NCT03101501
Recruitment Status : Terminated (The manufacturing company of the Raindrop Corneal Inlay has stopped distribution or sales of the product.)
First Posted : April 5, 2017
Last Update Posted : August 13, 2019
Sponsor:
Information provided by (Responsible Party):
Jeffrey Whitman, MD, Key-Whitman Eye Center

Brief Summary:
The clinical objective of this study is to evaluate the Raindrop® Near Vision Inlay for the improvement of near vision in presbyopic or pseudophakic patients treated with low dose Mitomycin C immediately following femtosecond flap creation.

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

Detailed Description:
The scientific objective of this study is to evaluate the postoperative incidence of corneal reaction in patients treated with low dose Mitomycin C, immediately following femtosecond flap creation (LASIK correction if needed), and before implantation with the Raindrop corneal inlay in the non-dominant eye. The postoperative incidence of haze, visible by broad tangential illumination of the slit lamp, is known to adversely impact the safety and efficacy of the Raindrop corneal inlay. Three main strategies have been employed to minimize haze incidence after surgery: (i) perfection of the surgical technique, (ii) deeper implantation in the cornea, and (iii) extension of the steroid regimen after surgery. Haze has also been observed after another type of corneal refractive procedure, Photorefractive Keratectomy (PRK). Several prospective studies have shown that Mitomycin C, applied immediately following the PRK laser procedure, is effective in reducing the postoperative incidence of haze.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 9 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Prospective Study To Evaluate The Raindrop Near Vision Inlay In Presybopic or Pseudophakic Patients Treated With Mitomycin C Following Femtosecond Flap Creation.
Actual Study Start Date : February 14, 2017
Actual Primary Completion Date : February 1, 2018
Actual Study Completion Date : February 1, 2018

Resource links provided by the National Library of Medicine



Intervention Details:
  • Drug: Mitomycin c
    Low dose mitomycin C at a concentration of 0.02% will be applied a duration of 10 to 30 seconds at the time of the surgical procedure.
  • Device: Raindrop Near Vision Inlay
    Implanted to improve near vision in Presbyopic or Pseudophakic subjects.


Primary Outcome Measures :
  1. Uncorrected Visual Acuity [ Time Frame: 24 months ]
    After the inlay procedure, patients will attain functional near visual acuity in the inlay eye and functional distance acuity binocularly.


Secondary Outcome Measures :
  1. Incidence of Corneal Reaction [ Time Frame: 24 months ]
    Patients treated with low dose mitomycin C will have minimal levels of corneal reaction.

  2. Endothelial Cell Count (measured by Konan Specular Microscope) [ Time Frame: 24 months ]
    Patients treated with low dose mitomycin C will not lose more than 10% of their endothelial cell count from the preoperative measurement



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Ages Eligible for Study:   41 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

4.2.1 Presbyopic patients 41-65 years of age.

4.2.2 Pseudophakic patients at least 50 years of age.

4.2.3 Patients require a near reading add from +1.50 to +2.50 D in the non-dominant eye.

4.2.4 Patients have a photopic pupil size of at least 3.0 mm in the non-dominant eye.

4.2.5 Patients have a corneal thickness greater than or equal to 500 microns in the non-dominant eye.

4.2.6 Patients have corrected distance and near visual acuity of 20/25 or better in each eye.

4.2.7 Patients have distance corrected near visual acuity of 20/40 or worse in each eye.

4.2.8 Patients have no more than a 0.75 D difference at preop between MRSE and cycloplegic refraction spherical equivalent determined at the spectacle plane of each eye.

4.2.9 Patients have targeted MRSE from -0.5 to +1.0 D in the non-dominant eye, with no more than 0.75 D of manifest cylinder with or without LASIK.

4.2.10 Patients are willing and able to sign a written Informed Consent Form prior to any study-specific procedures.

4.2.11 Pseudophakic patients must be at least 3 months after cataract surgery.

4.2.12 Pseudophakic patients must have clear posterior capsule, open posterior capsule (post YAG Capsulotomy), or posterior capsule opacification that is not clinically significant at the opinion of the investigator.

4.2.13 Patients are willing and able to return for scheduled follow-up examinations for 24 months after the corneal inlay surgery.

Exclusion Criteria

4.3.1 Patients with prior corneal surgery including LASIK surgery in the non-dominant eye. (Not including Astigmatic Keratotomy or Limbal Relaxing Incisions)

4.3.2 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.

4.3.3 Patients with a planned corneal residual bed thickness that is less than 300 microns (corneal thickness - (intended ablation depth + intended flap thickness)).

4.3.4 Patients with clinically significant macular pathology based on dilated fundus exam and/or optical coherence tomography (OCT) image.

4.3.5 Patients who would be co-managed by an ophthalmologist or optometrist who is not an approved sub-investigator.

4.3.6 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 in the investigator's opinion.

4.3.7 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, or any other medications in the investigator's opinion.

4.3.8 Patients with known sensitivity to any planned study medications.

4.3.9 Patients with residual, recurrent, active or uncontrolled eyelid disease.

4.3.10 Patients with significant corneal asymmetry or irregular topography.

4.3.11 Patients with clinically significant anterior segment pathology.

4.3.12 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.

4.3.13 Patients with ophthalmoscopic/topographic signs of keratoconus or those who are keratoconus suspect.

4.3.14 Patients with history of Herpes zoster or Herpes simplex keratitis.

4.3.15 Pseudophakic patients that have anterior chamber IOLs, multifocal IOLs, or extended range of vision IOLs in either eye.

4.3.16 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.

4.3.17 Patients with known history of steroid-responsive intraocular pressure increases, glaucoma, preoperative IOP > 21 mm Hg, or are otherwise suspected of having glaucoma.

4.3.18 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.

4.3.19 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.

4.3.20 Patients on chronic systemic corticosteroid or other immunosuppressive therapy that may affect wound healing at the opinion of the investigator.

4.3.21 Patients with any type of active cancer (ophthalmic or non-ophthalmic).

4.3.22 Patients with uncontrolled infections of any kind.

4.3.23 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.

4.3.24 Patients who actively participate in contact sports (i.e., boxing, martial arts) where impacts to the face and eye are a normal occurrence.

4.3.25 Patients participating in any other ophthalmic or non-ophthalmic drug/device clinical trials during the time of this clinical investigation.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03101501


Locations
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United States, Minnesota
Chu Vision Institue
Bloomington, Minnesota, United States, 55420
United States, Texas
Key-Whitman Eye Center
Dallas, Texas, United States, 75243
Parkhurst NuVision
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
Key-Whitman Eye Center
Investigators
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Principal Investigator: Jeffrey Whitman, M.D. Key-Whitman Eye Center

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Responsible Party: Jeffrey Whitman, MD, President and Chief Surgeon, Key-Whitman Eye Center
ClinicalTrials.gov Identifier: NCT03101501     History of Changes
Other Study ID Numbers: P17-001
First Posted: April 5, 2017    Key Record Dates
Last Update Posted: August 13, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Presbyopia
Refractive Errors
Eye Diseases
Mitomycins
Mitomycin
Antibiotics, Antineoplastic
Antineoplastic Agents
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors