trial of the presview implant for the improvement of near vision in patients with presbyopia

Conditions: Presbyopia

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.

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%

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.

Keywords: presbyopia reading vision near vision