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

NCT03101501 | Terminated Phase 4 FDA Drug FDA Device

• 1 other identifier: P17-001
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 3

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.

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

• Endothelial Cell Count (measured by Konan Specular Microscope)

  24 months

Study Arms (1)

MMC for fibrosis prevention

EXPERIMENTAL

no intervention is required after procedure is performed

Drug: Mitomycin c; Device: Raindrop Near Vision Inlay

Interventions

Mitomycin c DRUG

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.

MMC for fibrosis prevention

Raindrop Near Vision Inlay DEVICE

Implanted to improve near vision in Presbyopic or Pseudophakic subjects.

MMC for fibrosis prevention

Eligibility Criteria

• Age: 41 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Presbyopic patients 41-65 years of age.
• Pseudophakic patients at least 50 years of age.
• Patients require a near reading add from +1.50 to +2.50 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 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.
• 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.
• Patients are willing and able to sign a written Informed Consent Form prior to any study-specific procedures.
• Pseudophakic patients must be at least 3 months after cataract surgery.
• 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.
• 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 corneal surgery including LASIK surgery in the non-dominant eye. (Not including Astigmatic Keratotomy or Limbal Relaxing Incisions)
• 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 clinically significant 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 is not an approved sub-investigator.
• 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.
• 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.
• Patients with known sensitivity to any planned study medications.
• Patients with residual, recurrent, active or uncontrolled eyelid disease.
• Patients with significant corneal asymmetry or irregular topography.
• Patients with clinically significant anterior segment pathology.
• 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.
• Pseudophakic patients that have anterior chamber IOLs, multifocal IOLs, or extended range of vision IOLs in either eye.

Sponsors & Collaborators

• Key-Whitman Eye Center: lead

Study Sites (3)

Chu Vision Institue

Bloomington, Minnesota, 55420, United States

Location

Key-Whitman Eye Center

Dallas, Texas, 75243, United States

Location

Parkhurst NuVision

San Antonio, Texas, 78229, United States

Location

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

• Jeffrey Whitman, M.D.

  Key-Whitman Eye Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: President and Chief Surgeon

Study Record Dates

• First Submitted: March 30, 2017
• First Posted: April 5, 2017
• Study Start: February 14, 2017
• Primary Completion: February 1, 2018
• Study Completion: February 1, 2018
• Last Updated: August 18, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)