A Clinical Trial to Evaluate a Corneal Inlay for the Improvement of Near Vision in Presbyopic Patients

NCT01373580 | Completed Results

• 1 other identifier: P09-0003
• Study Type: interventional
• Target: 373
• Locations: 1 country
• Sites: 11

Brief Summary

This study will be a prospective, multicenter clinical trial in which a total of 400 subjects will be enrolled. All subjects will be followed over a 36 month time frame with a maximum of 15 clinical sites participating. Qualified subjects will provide informed consent for entry into the study.

Conditions

Presbyopia

Keywords

presbyopia; LASIK; loss of accommodation; Emmetrope

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Improvement in Uncorrected Near Visual Acuity (20/40 or Better) in the Implanted Eye

  75% of participants should achieve uncorrected near visual acuity in the implanted eye of 20/40 or better as compared to preoperative baseline

  24 Months

Secondary Outcomes (2)

• Number of Participants With no or Minimal Loss of Best Corrected Visual Acuity in the Implanted Eye

  at 6 months postoperative and all subsequent visits

• Number of Participants With Induced Manifest Refractive Astigmatism in the Implanted Eye

  At 6 months postoperative and all subsequent visits

Study Arms (1)

Raindrop

EXPERIMENTAL

A single-arm study to evaluate the effectiveness of a 2 mm corneal inlay (Raindrop Near Vision Inlay) for the treatment of presbyopia (age-related near vision loss). The anterior curvature of the cornea is re-shaped after implanting the Raindrop Near Vision Inlay in the non-dominant eye under a femtosecond laser flap to improve near vision.

Device: The Raindrop Near Vision Inlay

Interventions

The Raindrop Near Vision Inlay DEVICE

The Raindrop Near Vision Inlay is implanted in the cornea for treatment of presbyopia

Also known as: Presbylens

Raindrop

Eligibility Criteria

• Age: 35 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• must be presbyopic adults, needing from +1.50 to +2.50 or reading add must have uncorrected near visual acuity worse than 20/40 and better than 20/200in the eye to be implanted must have an uncorrected distance visual acuity of 20/25 or better in both eyes must have a distance visual acuity correctable to 20/20 in both eyes must have a near visual acuity correctable to 20/20 in both eyes must have a manifest refraction spherical equivalent between -0.50 and +1.00D in the eye to be implanted with no more than 0.75D of refractive cylinder must report stable vision, i.e. no change in distance vision and or MRSE within 0.50D over prior 12 months must discontinue hard or rigid gas permeable lenses for at least 3 weeks and discontinue soft lenses for at least 1 week prior to baseline examination must have a minimum central corneal thickness of \>500 microns in the eye to be implanted must have a mesopic pupil \< 7.0mm and photopic pupil \>3.0mm in the eye to be implanted subjects aged 45 years or younger must have an endothelial cell count

You may not qualify if:

• Subjects with a difference of \>0.75 between the manifest refraction spherical equivalent and the cycloplegic refraction spherical equivalent Subjects with anterior segment pathology, including clinically significant cataracts, in the non-dominant eye Subjects with residual, recurrent, active ocular or uncontrolled eyelid disease, or any corneal abnormality (including endothelial dystrophy, guttata, recurrent corneal erosion, etc.) in the non-dominant eye Subjects with ophthalmoscopic signs of keratoconus (or keratoconus suspect) in the non-dominant eye Subjects with clinically significant dry eyes, as determined by either the presence of greater than mild symptoms of dryness or discomfort or SPK greater than grade 1 Subjects with distorted or unclear mires on topography maps of the non-dominant eye Subjects with macular degeneration, retinal detachment, or any other fundus pathology that would prevent an acceptable visual outcome in the non-dominant eye Subjects who have undergone LASIK surgery in the non-dominant eye Subjects with a history of herpes zoster or herpes simplex keratitis Subjects who have a history of steroid responsive rise in intraocular pressure, pre-operative IOP\>21 mm Hg, glaucoma or are a glaucoma suspect Subjects with a history of diagnosed diabetes, autoimmune disease, connective tissue disease, or clinically significant atopic syndrome Subjects on chronic systemic corticosteroids or other immunosuppressive therapy that may affect wound healing, and any immunocompromised subjects Subjects who are using ophthalmic mediation(s) other than artificial tears for treatment of any ocular pathology Subjects using systemic medications with significant ocular side effects Subjects who are pregnant, lactating, or planning to become pregnant during the course of the study Subjects what are participating in any other ophthalmic drug or device studies during the time of this clinical investigation Subjects with known sensitivity to planned study concomitant medications

Sponsors & Collaborators

• ReVision Optics, Inc.: lead

Study Sites (11)

Dougherty Laser Vision

Camarillo, California, 93010, United States

Location

Harvard Eye Associates

Laguna Hills, California, 92653, United States

Location

Coastal Vision

Newport Beach, California, 92660, United States

Location

Jon G. Dishler, M.D.

Greenwood Village, Colorado, 80111, United States

Location

Eyesight Hawaai

Honolulu, Hawaii, 96816, United States

Location

Chu Vision

Bloomington, Minnesota, 55420, United States

Location

Key-Whitman Eye Center

Dallas, Texas, 75204, United States

Location

Carter Eye Center

Dallas, Texas, 75205, United States

Location

Slade and Baker Vision Center

Houston, Texas, 77027, United States

Location

Lehmann Eye Center

Nacogdoches, Texas, 75965, United States

Location

NuVision.

San Antonio, Texas, 78229, United States

Location

Related Publications (1)

• Whitman J, Dougherty PJ, Parkhurst GD, Olkowski J, Slade SG, Hovanesian J, Chu R, Dishler J, Tran DB, Lehmann R, Carter H, Steinert RF, Koch DD. Treatment of Presbyopia in Emmetropes Using a Shape-Changing Corneal Inlay: One-Year Clinical Outcomes. Ophthalmology. 2016 Mar;123(3):466-75. doi: 10.1016/j.ophtha.2015.11.011. Epub 2016 Jan 27.

  PMID: 26804761 DERIVED

MeSH Terms

Conditions

Presbyopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Results Point of Contact

• Title: Tracy Shwaery, Global Clinical Research Manager
• Organization: ReVision Optics

tshwaery@revisionoptics.com

9497072740

Study Officials

• Steven G Slade, M.D.

  PRINCIPAL INVESTIGATOR

• Jon G Dishler, MD

  PRINCIPAL INVESTIGATOR

• John Olkowski, M.D.

  PRINCIPAL INVESTIGATOR

• Dan B Tran, M.D.

  PRINCIPAL INVESTIGATOR

• Ralph Y Chu, M.D.

  PRINCIPAL INVESTIGATOR

• Jeffrey Whitman, M.D.

  PRINCIPAL INVESTIGATOR

• Robert P Lehmann, M.D.

  PRINCIPAL INVESTIGATOR

• Gregory Parkhurst, M.D

  Unaffilliated

  PRINCIPAL INVESTIGATOR

• Harvey L Carter, III, M.D.

  Unaffilliated

  PRINCIPAL INVESTIGATOR

• Paul Dougherty, M.D.

  Unaffilliated

  PRINCIPAL INVESTIGATOR

• John Hovanesian, M.D.

  Unaffilliated

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 13, 2011
• First Posted: June 15, 2011
• Study Start: April 1, 2010
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: March 29, 2018
• Results First Posted: March 29, 2018

Record last verified: 2018-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (11)