Ignite Creation Date:
2025-12-24 @ 5:38 PM
Ignite Modification Date:
2025-12-28 @ 8:56 AM
Study NCT ID:
NCT01166568
Status:
COMPLETED
Last Update Posted:
2018-09-28
First Post:
2010-07-16
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Trial of the PresVIEW Implant for the Improvement of Near Vision in Patients With Presbyopia
Sponsor:
Refocus Group, Inc.
Organization:
Study Overview
Official Title:
A Prospective, Multicenter Clinical Trial Of the PresVIEW Scleral Implant (PSI) For the Improvement Of Near Visual Acuity In Presbyopic Patients
Status:
COMPLETED
Status Verified Date:
2018-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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%
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: