N/A
N=16
Trial of the PresVIEW Implant for the Improvement of Near Vision in Patients With Presbyopia
Presbyopia
Bottom Line
View on ClinicalTrials.gov: NCT01166568 ↗Enrolled (actual)
16
Serious AEs
0.9%
Results posted
Sep 2018
Primary outcome: Primary: Number of Primary Eyes With Distance Corrected Near Visual Acuity (DCNVA) to 20/40 or Better or Improvement of 2 or More Lines — 288 Primary Eyes — p=0.025
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- PresVIEW Scleral Implants (Device)
- Age
- Adult · 50+ yrs
- Sex
- All
- Sponsor
- Refocus Group, Inc.
- Primary completion
- Mar 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Primary Eyes With Distance Corrected Near Visual Acuity (DCNVA) to 20/40 or Better or Improvement of 2 or More Lines |
288 | 0.025 sig |
| SECONDARY Presence of Significant Safety Events (SAEs). |
3 | — |
Summary
The primary objective of this study is to evaluate the safety and effectiveness of the PresVIEW™ Scleral Implant (PSI) for the improvement of near visual acuity in presbyopic patients.
Eligibility Criteria
Inclusion Criteria
- Subject must be between 50-60 years old
- Subject must have a best corrected distance visual acuity of 20/20 or better
- Subject must have SLOAN distance corrected near visual acuity @ 40cm in the operative eye/eyes of 20/50 to 20/100 (inclusive).
- Subject should have a manifest distance spherical equivalent refractive correction in the operative eye/eyes of from -0.50 to +0.75 diopters with no more than 1.00 diopter of astigmatism and should require at least a +1.50 diopter add. The distance manifest refraction spherical equivalent and the distance cycloplegic refraction spherical equivalent must be within 0.50 diopters of each other.
- Subject must be phakic in the study eye
- Subject must be mentally competent to understand and comply with the requirements of the study.
- Subject must be able to provide written informed consent.
Exclusion Criteria
- Chronic uveitis or other recurrent anterior or posterior segment inflammation in either eye.
- Scleral thickness less than 530 μm in the operative eye/eyes.
- Any previous eye surgeries including cataract, LASIK, or Muscle surgery
- Any history of prior extraocular muscle surgery, specifically the recti or oblique muscles.
- Any chronic systemic diseases such as diabetes, heart disease, Lupus, etc.
- Any eye diseases such as eye inflammation, infection, cataract, or retinal diseases
- Allergic to any medications used in the study.
- The patient may not have participated in a device clinical study for the operative eye within the last 3 months and may not have been implanted with PSI devices in this or any other study.
Data sourced from ClinicalTrials.gov (NCT01166568). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.