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TerminatedNCT03145116UVEA509Updated Jul 18, 2018

Clinical Safety and Efficacy of CT ASPHINA 509 Lenses

An interventional study of CT ASPHINA 509 in Cataract, sponsored by Carl Zeiss Meditec AG. Terminated at 1 site in Germany. Per ClinicalTrials.gov, last updated 2018-07-18.

Sponsored by Carl Zeiss Meditec AG · Not applicable, Interventional, and Treatment

Why this study was terminated
recruitment rate
Phase
Not applicable
Study type
Interventional
Enrollment
95
Allocation
Not applicable
Sex
All
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Study summary

Clinical safety and efficacy of CT ASPHINA 509 IOLs after implantation

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Conditions studied

  • Cataract

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In context

Cataract

1,701 studies on the registry are indexed under Cataract; 230 are open to participants now.

This study's enrollment of 95 is above the median of 80 across 1,155 interventional studies indexed under Cataract.

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Lead sponsor

Carl Zeiss Meditec AG is the lead sponsor of 37 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

Patient informed of the consequences and constraints of the protocol and who has given his/her written informed consent;

  • Patients of any gender
  • Assured follow-up examinations
  • Biometry measurement preferably compatible with the IOLMaster evaluation;
  • IOL implanted into the capsular bag with IOL model CT ASPHINA 409MP (UVE material) in one eye with at least 12 months follow up at the time of the postop visit
  • Patients who had uncomplicated (no peroperative complication) agedrelated cataract surgery in a healthy eye (beside clinically significant cataract)

Exclusion criteria

Exclusion Criteria:

    • BCVA not available preoperatively or better than 0.3 logMAR pre-op

      • Patients unable to meet the limitations of the protocol or likely of noncooperation during the trial
      • Patients whose freedom is impaired by administrative or legal order
      • Concurrent participation in another drug or device investigation
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
95 participants (actual)

Study arms

  • Experimental
    509

    Device: CT ASPHINA 509

Interventions

  • DeviceCT ASPHINA 509

    Intraocular lens

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What researchers measure

Primary outcomes

  1. Visual acuity

    Monocular best corrected distance visual acuity

    Time frame: 12 to 18 months after surgery

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Study locations

1 site
  • Augenklinink
    Ahaus, 12593, Germany
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 18, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03145116
Lead sponsor
Carl Zeiss Meditec AG
Responsible party
Sponsor
First posted
May 9, 2017
Start date
Sep 22, 2017
Primary completion
Feb 5, 2018
Completion
Feb 5, 2018
Last update
Jul 18, 2018

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Jan 2018. You cannot join it, but the record below documents what was studied.

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Discussion

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