A Continuation Study To Monitor The Long Term Safety Of Patients Completing Protocols ACU-P08-020/020A

A

AcuFocus

Status

Completed

Conditions

Presbyopia

Treatments

Device: AcuFocus Corneal Inlay ACI 7000 PDT

Study type

Interventional

Funder types

Industry

Identifiers

NCT01895088
ACU-P12-020C

Details and patient eligibility

About

This is a 2 year follow up study to monitor the long term safety of the ACI 7000PDT in subjects who are still implanted with the ACI and have successfully completed the ACU-P08-020/020A studies.

Full description

This is a two year follow up study designed to monitor and obtain long-term safety data of the ACI 7000PDT in subjects who participated and successfully completed the ACU-P08-020/020A studies. Subjects must be able to provide voluntary informed consent, and must sign and be given a copy of the written Informed Consent form prior to participating. This continuation study follows subjects still implanted with the ACI and includes two visits, at 12-month intervals, after subjects have been exited (at Month 36) from the ACU-P08-020/020A studies. The first visit is at Month 48 following implantation followed by a final Month 60 visit. The study parameters being measured at these two visits include: Specular microscopy Slit lamp and fundus examination (ocular health) Corrected and uncorrected visual acuity Manifest mid-point refraction Corneal topography Dry eye assessment Mesopic and Photopic contrast sensitivity Adverse events and complications All sites participating in the ACU-P08-020/020A studies were invited to participate in the continuation study.

Enrollment

271 patients

Sex

All

Ages

45 to 60 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Patients must have completed participation in the ACU-P08-020/020A clinical trial.
  • Patients must be able to provide voluntary informed consent, and must sign and be given a copy of the written Informed Consent form.

Exclusion criteria

Patients who did not complete ACU-P08-020/020A.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

271 participants in 1 patient group

Patients prev. impl. with ACI 7000 PDT
Experimental group
Description:
AcuFocus Corneal Inlay ACI 7000 PDT
Treatment:
Device: AcuFocus Corneal Inlay ACI 7000 PDT

Trial contacts and locations

13

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Data sourced from clinicaltrials.gov

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