Trial of the PresVIEW Implant for the Improvement of Near Vision in Patients With Presbyopia

Refocus Group

Status: Completed

Conditions: Presbyopia

Treatments: Device: PresVIEW Scleral Implants

Study type: Interventional

Funder types: Industry

Identifiers

NCT01166568

P-277-5

Details and patient eligibility

About

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.

Full description

The clinical investigation of the PresView™ Scleral Implant (PSI) is a prospective multicenter clinical trial in which a total of 330 subjects were enrolled and implanted with the PSI and followed for a period of 24 months at up to 14 clinical sites.

An additional randomized sub-study was performed on 48 subjects with the PSI Second Generation PresView™(SGP) implant, model number SGP-046. A 2:1 randomization was used to determine the 32 subjects assigned to be implanted and the 16 subjects assigned to the observation/deferred implantation control arm. Subjects randomized to the deferred implantation control arm were eligible to receive the PSI after completion of the 6 months of observation in the study.

All subjects interested in participating in the study were screened for eligibility, and informed consent was obtained from those who meet the inclusion/exclusion criteria. Eligible subjects were examined preoperatively to obtain a medical history and baseline ocular data.

Effectiveness: The following tests/measurements used to evaluate the effectiveness of the PSI procedure will be included in the study protocol:

• Near visual acuity of the operated eye/eyes as compared with baseline (uncorrected and distance corrected)
• Reading acuity of the operated eye/eyes as compared with baseline (uncorrected and distance corrected)

The PSI procedure will be defined as successful if a logMar equivalent to Snellen 20/40 or better (logMar 0.3) is achieved in ≥ 75% of patients or if 75% of patients realize an improvement ≥ 2 lines in distance corrected near visual acuity (DCNVA). For most patients, this will translate into the ability to read the majority of newspaper and magazine print without a near optical aid.

Safety: Primary safety outcomes for safety will include:

• Incidence of anterior segment ischemia
• Decrease in Best Corrected Distance Visual Acuity (BCDVA) of more than 2 lines from baseline at 1-month or more postoperatively
• Decrease in best distance corrected near acuity (with add) of more than 2 lines from baseline at 1-month or more postoperatively
• Intraocular Pressure (IOP) increase > 10mm Hg over baseline or IOP > 25mm Hg after 1 Day postoperative
• Signs of chronic inflammation (e.g. uveitis or chronic conjunctival hyperemia) at 2 months or more postoperatively
• Increase in axial length of ≥ 0.20mm accompanied by a > 0.5 diopter myopic shift in manifest spherical equivalent distance refraction.
• Incidence of adverse events: total not to exceed 5%, and the incidence of each event should not exceed 1-2%

Enrollment: 337 patients

Sex: All

Ages: 50 to 60 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

337 participants in 3 patient groups

Implantation-Non Randomized

Experimental group

Description:

Subjects are not participants in the randomized sub-study. PresView Scleral Implants surgical placed in the eye(s) after enrollment and meeting inclusion/exclusion criteria.

Treatment:

Device: PresVIEW Scleral Implants

Implantation-Randomized

Experimental group

Description:

Subjects are participants in the randomized sub-study. Subjects were randomized to the Immediate Treatment group. PresView Scleral Implants surgical placed in the eye(s)Subjects are participants in the randomized sub-study after enrollment and meeting inclusion/exclusion criteria.

Treatment:

Device: PresVIEW Scleral Implants

Deferred Implantation-Randomized

No Intervention group

Description:

Subjects are participants in the randomized sub-study after enrollment and meeting inclusion/exclusion criteria. Subjects were randomized to the Deferred Treatment group are observed for 6 months. Upon completion of the observation follow-up, subjects can opt to have PresView Scleral Implants surgically placed in the eye(s) and become part of the overall study experimental group.