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NCT01191229 · ClinicalTrials.gov registry record · Phase 4
Prospective Evaluation of Visual Outcomes With Tecnis One-Piece Multifocal Intraocular Lenses Compared With Patients Previously Implanted With Crystalens Aspheric Optic (AO)
A Phase 4 study, sponsored by Innovative Medical.
- Completed
- Registry status
- Phase 4
- Development phase
- 12
- Enrollment target
NCT01191229: Completed Phase 4 study, sponsored by Innovative Medical.
NCT01191229 is a Phase 4 study that has completed, run by Innovative Medical. The registered enrollment target is 12 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01191229, a Phase 4 study, has completed, sponsored by Innovative Medical.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 12 participants
- Enrollment target
Study Summary
The study is being conducted to collect information about visual outcomes and participant satisfaction with the Tecnis One-Piece Multifocal (MF) Intraocular Lenses (IOLs) compared with participants previously implanted with Crystalens Aspheric Optic (AO) IOLs. The U.S. Food and Drug Administration (FDA) has cleared the Tecnis One-Piece MF IOL for visual correction of aphakia (replacing a removed lens in the eye) in adults.
Primary Outcome
Part 1 Only: The primary outcome measure is incision size at three points: Immediately after application of the keratome blade Post phacoemulsification Post Tecnis IOL implantation Target refraction vs. achieved Part 1 and 2: UCVA data at distance, intermediate, and near Near vision will be measured in mesopic and photopic conditions standardized with light meter BCVA at distance and near Enhancement rates Spectacle independence questionnaire and patient satisfaction Incidence of adverse eve
Interventions
- DEVICE Crystalens AO
- DEVICE Tecnis one-piece MF IOL
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2010-07 |
| Est. Completion | 2012-06 |
| Phase | Phase 4 |
What the finished NCT01191229 record still lists
NCT01191229 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 2 interventions - of which Crystalens AO is the first listed.
NCT01191229 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01191229 about?
NCT01191229 is a clinical study titled "Prospective Evaluation of Visual Outcomes With Tecnis One-Piece Multifocal Intraocular Lenses Compared With Patients Previously Implanted With Crystalens Aspheric Optic (AO)". The study is being conducted to collect information about visual outcomes and participant satisfaction with the Tecnis One-Piece Multifocal (MF) Intraocular Lenses (IOLs) compared with participants previously implanted with Crystalens Aspheric Optic (AO) IOLs. The U.S. Food and Drug Administration (...
What is the current status of trial NCT01191229?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 12 participants. The study started on 2010-07. Estimated completion is 2012-06.
What interventions are being tested in trial NCT01191229?
The interventions under investigation include: Crystalens AO (DEVICE), Tecnis one-piece MF IOL (DEVICE).
Who is sponsoring clinical trial NCT01191229?
This trial is sponsored by Innovative Medical, which has 44 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01191229's enrollment target sits among peer trials
12 1913th of 2000 higher than 70 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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