Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 5:38 PM
Ignite Modification Date:
2025-12-24 @ 5:38 PM
NCT ID:
NCT01166568
Brief 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.
Detailed 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%
Study:
NCT01166568
Study Brief:
Protocol Section:
NCT01166568