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

Presbyopia Clinical Trial

Official title:

A Prospective, Multicenter, Controlled Clinical Study of the PresVIEW Scleral Implant for the Improvement of Near Visual Acuity in Presbyopic Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01933750
• Other study ID #: EU-001
• Status: Completed
• Phase: N/A
• First received: August 28, 2013
• Last updated: April 4, 2016
• Start date: February 2013
• Est. completion date: March 2016

Study information

• Verified date: April 2016
• Source: Refocus Ocular Europe, B.V.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: National Health Service, Health Research Authority
• Study type: Interventional

Clinical Trial Summary

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

Other known NCT identifiers

• NCT01910207

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 45 Years to 60 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Presbyopia

Intervention

Device:
• PresVIEW Device Implantation

Locations

Country	Name	City	State
United Kingdom	Midland Eye	Birmingham

Sponsors (1)

Lead Sponsor	Collaborator
Refocus Ocular Europe, B.V.

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Near Visual Acuity	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	12 Months	No
Secondary	Uncorrected Near Visual Acuity	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	12 Months	No
Secondary	Presence of Significant Safety Events	Several indicators of safety are monitored including but not limited to Best Corrected Distance Visual Acuity, Intra-ocular Pressure, and Chronic Inflammation.	24 months	Yes