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NCT00819299 · ClinicalTrials.gov registry record · NA

Safety and Effectiveness Study of the AcuFocus Corneal Inlay ACI 7000PDT in Presbyopes

A NA study of Presbyopia, sponsored by AcuFocus.

Completed
Registry status
NA
Development phase
359
Enrollment target
15
Study locations

NCT00819299: Completed NA study of Presbyopia, sponsored by AcuFocus.

NCT00819299 is a NA study of Presbyopia that has completed, run by AcuFocus. The registered enrollment target is 359 participants, above the 261-participant average among 38 other Presbyopia trials with a reported enrollment target (38% higher). The trial reports 15 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00819299, a NA study of Presbyopia, has completed, sponsored by AcuFocus.

COMPLETED
Registry status
NA
Development phase
359 participants
Enrollment target
15
Study locations

Study Summary

The purpose of this study is to determine if the AcuFocus Corneal Inlay ACI 7000PDT will provide an effective method for the correction of presbyopia in patients who have normal distance vision but need a correction such as glasses or contact lenses to see clearly at near.

Primary Outcome

Increased depth of focus created by the small aperture of the ACI to improve near visual acuity, while maintaining a range of focus over intermediate and distance.

Conditions Studied

Interventions

  • DEVICE AcuFocus Corneal Inlay ACI 7000PDT

Study Locations (15)

California

  • Maloney Vision - Los Angeles
  • TLC Laser Eye Center - Newport Beach
  • Gordon Binder Weiss Vision Institute - San Diego

Arkansas

  • McDonald Eye Associates - Fayetteville

Colorado

  • Eye Center NOCO - Fort Collins

Illinois

  • Kraff Eye Institute - Chicago

Indiana

  • Eye Surgeons of Indiana - Indianapolis

Kansas

  • Durrie Vision - Overland Park

Missouri

  • Pepose Vision Institute - Chesterfield

New Jersey

  • The Cornea & Laser Eye Institute, P.A - Teaneck

Trial Details

FieldValue
Enrollment Target 359 participants
Start Date 2008-12
Est. Completion 2013-09
Phase NA
AcuFocus

4 total trials

What the finished NCT00819299 record still lists

NCT00819299 is an interventional study that assigns participants to a tested intervention. The registered 359 participants enrollment target is mid-sized for trials with a published cap, above the 261-participant average among 38 other Presbyopia trials with a reported enrollment target (38% higher).

The record links to 1 condition, with Presbyopia appearing as the primary indexed condition, and to 1 intervention - of which AcuFocus Corneal Inlay ACI 7000PDT is the first listed.

NCT00819299 lists 15 locations in 13 states (California, Arkansas, Colorado).

Frequently Asked Questions

What is clinical trial NCT00819299 about?

NCT00819299 is a clinical study titled "Safety and Effectiveness Study of the AcuFocus Corneal Inlay ACI 7000PDT in Presbyopes". The purpose of this study is to determine if the AcuFocus Corneal Inlay ACI 7000PDT will provide an effective method for the correction of presbyopia in patients who have normal distance vision but need a correction such as glasses or contact lenses to see clearly at near.

What is the current status of trial NCT00819299?

This trial is currently completed. It is a NA study. The enrollment target is 359 participants. The study started on 2008-12. Estimated completion is 2013-09.

What conditions does trial NCT00819299 study?

This clinical trial studies the following conditions: Presbyopia.

What interventions are being tested in trial NCT00819299?

The interventions under investigation include: AcuFocus Corneal Inlay ACI 7000PDT (DEVICE).

Who is sponsoring clinical trial NCT00819299?

This trial is sponsored by AcuFocus, which has 4 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00819299 being conducted?

This trial has 15 study locations across Arkansas, California, Colorado, Illinois, Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Presbyopia

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT00819299's enrollment target sits among peer trials

359 7th of 38 higher than 32 of 38 other Presbyopia trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Presbyopia trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00819299, the US trial registry maintained by the National Library of Medicine. NCT00819299 (mid enrollment · multi site footprint · completed) retrieved and formatted by PlainTrial, see methodology.