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OpenTrials
Completed

NCT Number: NCT01933750

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

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

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Key information

Conditions

Presbyopia Eye Diseases Myopia Refractive Errors

Age range

45 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Midland Eye

Birmingham, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PresVIEW Device Implantation

Device

Primary outcomes

  1. Near Visual Acuity

    Time frame: 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 outcomes

  1. Uncorrected Near Visual Acuity

    Time frame: 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

    Time frame: 24 months

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

Sponsors and collaborators

Lead sponsor

Refocus Ocular Europe, B.V.

Industry

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Sep 2, 2013
Registry last updated
Apr 6, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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