Post-Approval Study of the Implantable Miniature Telescope

Conditions

• AMD

Eligibility Criteria

Sex

ALL

Age

65 Years - N/A

Healthy Volunteers

Accepted

Interventions

• Implantable Miniature Telescope — DEVICE
  Device - Implantable Miniature Telescope

Study Details

The objective of the PAS-01 study is to assess the safety of the intraocular as measured by the cumulative incidence of patients who within 5 years after implantation experience persistent vision-impairing corneal edema (corneal edema leading to persistent loss of best corrected distance visual acuity \>2 lines from pre-surgery baseline level). The study will test the null hypothesis that the percentage of patients who experience persistent vision-impairing corneal edema is \>17% against the alternative that the percentage is \<17%. The null hypothesis will be rejected if the upper bound of the two-sided 95% confidence integral for the observed percentage is \<17%.

Key Dates

Start date

Aug 31, 2010

Status verified

Nov 2018

Primary completion

Dec 31, 2023

Completion

Dec 31, 2028

Study Design

Enrollment

770 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

OTHER

Arms

• Other: Implantable Miniature Telescope
  Post approval study

Primary Outcome Measure

Long term safety study of implantable miniature telescope [ Time Frame: 5 years after implantation ]

Locations (16)

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