Trial of the PresView Implant for the Improvement of Near Vision in Presbyopic Patients

• Sponsor: Refocus Ocular Europe, B.V. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01933750
• Collaborator: (none)
• Enrollment: 20
• Location: 1
• Arms: 2
• Duration (Months): 36.9
• Patients Per Site Per Month: 0.5

Study Details

Study Description

Brief Summary

Study to determine the effectiveness of the PresVIEW Scleral Implant to improve near vision in patients who require reading glasses

Condition or Disease	Intervention/Treatment	Phase
Presbyopia	Device: PresVIEW Device Implantation	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 20 participants
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Prospective, Multicenter, Controlled Clinical Study of the PresVIEW Scleral Implant for the Improvement of Near Visual Acuity in Presbyopic Patients
• Study Start Date: Feb 1, 2013
• Actual Primary Completion Date: Mar 1, 2016
• Actual Study Completion Date: Mar 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Randomized/Control 7 patients randomized to deferred treatment/control cohort at the 3 sub-study control sites = 21
Experimental: Non-Randomized/Treatment Patients are non-randomized and if meet inclusion criteria receive the implantation of the PresVIEW device	Device: PresVIEW Device Implantation

Outcome Measures

Primary Outcome Measures

1. Near Visual Acuity [12 Months]

   Measurement of the distance Corrected Near Visual Acuity at 40 centimeters compared to baseline measurement. A minimum of 75% of patients with a bilateral post-operative Distance Corrected Near Visual Acuity of .5 (20/40) or better at 12 months

Secondary Outcome Measures

1. Uncorrected Near Visual Acuity [12 Months]

   The percent of patients with a bilateral post-operative uncorrected near visual acuity (UCNVA) at 40 centimeters of .5 (20/40) or better at 12 months

2. Presence of Significant Safety Events [24 months]

   Several indicators of safety are monitored including but not limited to Best Corrected Distance Visual Acuity, Intra-ocular Pressure, and Chronic Inflammation.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 45 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Age 45 or older at commencement of study

• Best Corrected Distance Visual Acuity of .80 (20/25) or better

• Patients must be alert, mentally competent, and able to comply with clinical study requirements

Exclusion Criteria:

• Any previous eye surgeries including cataract, LASIK (laser in situ keratomileusis), or eye muscle surgery

• Any chronic systemic diseases such as diabetes, heart disease, Lupus, etc.

• Any eye diseases such as eye inflammation, infection, cataract, or retinal diseases

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Midland Eye	Birmingham		United Kingdom

Sponsors and Collaborators

• Refocus Ocular Europe, B.V.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Refocus Ocular Europe, B.V.
• ClinicalTrials.gov Identifier: NCT01933750
• Other Study ID Numbers: EU-001; NCT01910207
• First Posted: Sep 2, 2013
• Last Update Posted: Apr 6, 2016
• Last Verified: Apr 1, 2016

• Keywords provided by Refocus Ocular Europe, B.V.: Presbyopia; Reading Glasses; Near Vision
• Additional relevant MeSH terms: Presbyopia

Study Results

No Results Posted as of Apr 6, 2016