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

A Prospective, Multicenter Clinical Trial Of the PresVIEW Scleral Implant (PSI) For the Improvement Of Near Visual Acuity In Presbyopic Patients

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01166568

Enrollment

337

Registered

2010-07-21

Start date

2003-12-31

Completion date

2015-03-31

Last updated

2018-09-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Presbyopia

Keywords

Presbyopia, Reading Vision, Near Vision

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%

Interventions

DEVICEPresVIEW Scleral Implants

Subjects are implanted with the PresView Scleral Spacing Implants and followed for 24 months.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Intervention model description

A non-randomized arm was run in parallel with a randomized sub-study consisting of 2 arms; Immediate Treatment and Deferred Treatment. Upon completion of the 6 month observation period, the Deferred Treatment group then crosses over upon implantation to become part of the overall study group.

Eligibility

Sex/Gender

ALL

Age

50 Years to 60 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
Number of Primary Eyes With Distance Corrected Near Visual Acuity (DCNVA) to 20/40 or Better or Improvement of 2 or More Lines	From date of baseline measurement until the date of study withdrawal or study completion, whichever came first, assessed up to 2 years.	Measurement of the Distance Corrected Near Visual Acuity at 40 centimeters achieving 20/40 or better or improvement of 2 or more lines at 24 months for the primary eye.

Secondary

Measure	Time frame	Description
Presence of Significant Safety Events (SAEs).	From initiation of the implantation procedure (operative day) until study completion at 24 months or withdrawal from the study.	The point estimate were calculated for clinically significant adverse events (SAE's) at the end of the study. Incidence of adverse event totals should not to exceed 5%, and the incidence of each event should not exceed 1-2%. NOTE: Because the secondary outcome is a safety measure, both primary and fellow eyes were used for analysis.

Other

Measure	Time frame	Description
Safety Parameter Point Estimate -- Decrease in BCNVA > 2 Lines	From initiation of the implantation procedure (operative day) until study completion at 24 months or withdrawal from the study.	All primary and fellow eyes implanted with the PSI were included in the safety analysis. Point estimates were calculated for the incidence of Decrease in BCNVA \> 2 lines at the end of the study. Incidence of adverse event totals should not to exceed 5%, and the incidence of each event should not exceed 1-2%. NOTE: Because the secondary outcome is a safety measure, both primary and fellow eyes were used for analysis.
Safety Parameter Point Estimate -- (IOP Increase > 10 mmHg) or (IOP > 25 mmHg)	From initiation of the implantation procedure (operative day) until study completion at 24 months or withdrawal from the study.	All primary and fellow eyes implanted with the PSI were included in the safety analysis (i.e. both primary and fellow eyes). Point estimates were calculated for the incidence of (IOP Increase \> 10 mmHg) or (IOP \> 25 mmHg) at the end of the study. Incidence of adverse event totals should not to exceed 5%, and the incidence of each event should not exceed 1-2%. NOTE: Because the secondary outcome is a safety measure, both primary and fellow eyes were used for analysis.
Safety Parameter Point Estimate -- Anterior Segment Ischemia	From initiation of the implantation procedure (operative day) until study completion at 24 months or withdrawal from the study.	All primary and fellow eyes implanted with the PSI were included in the safety analysis. Point estimates were calculated for the incidence of Anterior Segment Ischemia at the end of the study. Incidence of adverse event totals should not to exceed 5%, and the incidence of each event should not exceed 1-2% NOTE: Because the secondary outcome is a safety measure, both primary and fellow eyes were used for analysis.
Safety Parameter Point Estimate -- (Axial Length Increase >= 0.20) AND (Myopic Shift > 0.50D MRSE)	From initiation of the implantation procedure (operative day) until study completion at 24 months or withdrawal from the study.	All primary and fellow eyes implanted with the PSI were included in the safety analysis. Point estimates were calculated for the incidence of (Axial Length Increase \>= 0.20) AND (Myopic Shift \> 0.50D MRSE) at the end of the study. Incidence of adverse event totals should not to exceed 5%, and the incidence of each event should not exceed 1-2%. NOTE: Because the secondary outcome is a safety measure, both primary and fellow eyes were used for analysis.
Safety Parameter Point Estimate -- Chronic Inflammation	From initiation of the implantation procedure (operative day) until study completion at 24 months or withdrawal from the study.	All primary and fellow eyes implanted with the PSI were included in the safety analysis. Point estimates were calculated for the incidence of Chronic Inflammation at the end of the study. Incidence of adverse event totals should not to exceed 5%, and the incidence of each event should not exceed 1-2%. NOTE: Because the secondary outcome is a safety measure, both primary and fellow eyes were used for analysis.
Safety Parameter Point Estimate -- Decrease in BCDVA > 2 Lines	From initiation of the implantation procedure (operative day) until study completion at 24 months or withdrawal from the study.	All primary and fellow eyes implanted with the PSI were included in the safety analysis. Point estimates were calculated for the incidence of Decrease in BCDVA \> 2 lines at the end of the study. Incidence of adverse event totals should not to exceed 5%, and the incidence of each event should not exceed 1-2%. NOTE: Because the secondary outcome is a safety measure, both primary and fellow eyes were used for analysis.

Countries

United States

Participant flow

Recruitment details

The prospective, multicenter clinical trial of the PresView Implant was conducted at 14 clinical sites. All recruitment evaluations were performed at the Principal Investigator's sites and subjects were screened for eligibility. If inclusion/exclusion criteria were met, informed consent was obtained and the subject was enrolled in the study.

Pre-assignment details

Once determined eligible and informed consent was obtained, both eyes were enrolled in the study. Per protocol, primary outcome analysis must be performed on the primary eye only and the primary eye is therefore the unit of analysis. Fellow eyes were followed for safety outcomes and summarized separately.

Participants by arm

Arm	Count
PresVIEW Implantation Non-Randomized 288 subjects that received the PresView Scleral Implants, which were surgical placed in the sclera of the eye. Subjects were followed for 24 months. This sample consists of; 16 randomized deferred implantation subjects, 32 randomized implantation subjects, and 282 non-randomized implanted subjects (i.e. all enrolled subjects).	288
PresVIEW Implantation - Randomized 33 randomized subjects entered into a immediate treatment (implantation) group. Subjects were followed for 24 months. Immediate treatment group data was compared to the Deferred Treatment group at 6 months.	33
PresVIEW Deferred Implantation - Randomized 16 randomized subjects entered into a deferred treatment (control) group arm. Subjects were followed for 6 months (observation). Subjects that completed the 6 month observation were then offered PresVIEW implantation.	16
Total	337

Withdrawals & dropouts

Period	Reason	FG000	FG001	FG002
Deferred Implantation- Randomized	Withdrawal by Subject	0	0	1
Implantation- Nonrandomized & Randomized	Lost to Follow-up	7	1	0
Implantation- Nonrandomized & Randomized	Withdrawal by Subject	7	0	1

Baseline characteristics

Characteristic	PresVIEW Implantation Non-Randomized	PresVIEW Implantation - Randomized	PresVIEW Deferred Implantation - Randomized	Total
Age, Continuous	54.92 Years STANDARD_DEVIATION 2.9	54.62 Years STANDARD_DEVIATION 2.96	55.03 Years STANDARD_DEVIATION 2.66	54.93 Years STANDARD_DEVIATION 2.88
DCNVA 20/40 or Better (at baseline)	1 Participants	0 Participants	0 Participants	1 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	32 Participants	6 Participants	2 Participants	40 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	256 Participants	27 Participants	14 Participants	297 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) American Indian or Alaska Native	4 Participants	0 Participants	0 Participants	4 Participants
Race (NIH/OMB) Asian	2 Participants	0 Participants	0 Participants	2 Participants
Race (NIH/OMB) Black or African American	12 Participants	0 Participants	0 Participants	12 Participants
Race (NIH/OMB) More than one race	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Unknown or Not Reported	12 Participants	6 Participants	2 Participants	20 Participants
Race (NIH/OMB) White	258 Participants	27 Participants	14 Participants	299 Participants
Region of Enrollment United States	288 Participants	33 Participants	16 Participants	337 Participants
Sex: Female, Male Female	128 Participants	15 Participants	8 Participants	151 Participants
Sex: Female, Male Male	160 Participants	18 Participants	8 Participants	186 Participants

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	— / —
other Total, other adverse events	143 / 330
serious Total, serious adverse events	3 / 330

Outcome results

Primary

Number of Primary Eyes With Distance Corrected Near Visual Acuity (DCNVA) to 20/40 or Better or Improvement of 2 or More Lines

Measurement of the Distance Corrected Near Visual Acuity at 40 centimeters achieving 20/40 or better or improvement of 2 or more lines at 24 months for the primary eye.

Time frame: From date of baseline measurement until the date of study withdrawal or study completion, whichever came first, assessed up to 2 years.

Population: Explanted primary eyes were analyzed as failures. Data for primary eyes that missed the 24 month visit, were lost to follow-up, or withdrew consent prior to the 24 month visit were not imputed. Per protocol, primary outcome analysis must be performed on the primary eye only. Fellow eye data is used for safety outcomes and summarized separately.

Arm	Measure	Value (COUNT_OF_UNITS)
Overall Study Population	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

Comparison: The PSI procedure is defined as successful if 75% of subjects achieve the first primary endpoint or second primary endpoint. The corresponding statistical hypotheses are as follows:~H0 (null hypothesis): p1 ≤ 0.75 Ha (alternative hypothesis): p1 \> 0.75, Where, p1 is the probability of subjects achieving the first primary endpoint. H0 (null hypothesis): p2 ≤ 0.75 Ha (alternative hypothesis): p2 \> 0.75, Where, p2 is the probability of subjects achieving the second primary endpoint.p-value: 0.025Fisher Exact

Secondary

Presence of Significant Safety Events (SAEs).

The point estimate were calculated for clinically significant adverse events (SAE's) at the end of the study. Incidence of adverse event totals should not to exceed 5%, and the incidence of each event should not exceed 1-2%. NOTE: Because the secondary outcome is a safety measure, both primary and fellow eyes were used for analysis.