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CompletedNCT06708806Updated Nov 27, 2024

Cell Ongrowth and Biocompatibility Study of Two Different (Hydrophobic Acrylic) Intraocular Lenses: IOL XY1 vs. IOL XY1A

An interventional study of cataract surgery in Cataract, sponsored by Medical University of Vienna. Completed at 1 site in Austria. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2024-11-27.

Sponsored by Medical University of Vienna · Not applicable, Interventional, and Diagnostic

From the registry’s dates

  • Registered 3 years 7 months after the study started (first participant enrolled Apr 2021, registered Nov 2024).
Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Not applicable
Ages
40 Years and older
Sex
All
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Study summary

The investigational devices are approved intraocular lenses (IOLs) intended to be implanted after phacoemulsification in individuals suffering from age-related cataract with the need of cataract surgery. Cataract surgery with precedent bilateral randomized IOL implantation will be performed in subjects who have signed an informed consent form. Postoperative examinations will be implemented in accordance with the approved investigational plan.

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Conditions studied

  • Cataract

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Keywords

  • Biocompatibility
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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 50 is below the median of 80 across 1,155 interventional studies indexed under Cataract.

Browse Cataract studies →

Lead sponsor

Medical University of Vienna is the lead sponsor of 1,076 studies on the registry; 177 are open to participants now.

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

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Who can participate

Ages eligible
40 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Bilateral age-related cataract for which phacoemulsification extraction and posterior IOL implantation is planned
  • Age 40 and older
  • Astigmatism of at least 0.75Diopters in one eye
  • Normal findings in medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant

Exclusion criteria

Exclusion Criteria:

  • Diabetes mellitus
  • Pseudoexfoliation syndrome
  • Systemical anticoagulation
  • Antiphlogistic therapy
  • Antiglaucomatosa
  • Uncontrolled systemic or ocular disease
  • Preceding ocular surgery or trauma
  • Intraoperative complications
  • Pregnancy/Nursing
  • Concurrently participating in any other clinical trial or if they have participated in any other clinical trial during the last 30 days
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Study design

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

Study arms

  • Other
    Toric vs Monofocal IOL

    The investigational devices are approved intraocular lenses (IOLs) intended to be implanted after phacoemulsification in individuals suffering from age-related cataract with the need of cataract surgery. In Arm one (I) participants will receive a monofocal IOL (XY1) vs. an toric IOL (XY1A)

    Procedure: cataract surgery

Interventions

  • Procedurecataract surgery

    bilateral cataract surgery including phacoemulsification in individuals suffering from age-related cataract and intraocular lens implantation of a monofocal IOL (XY1) vs. an toric IOL (XY1A)

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What researchers measure

Primary outcomes

  1. Foreign Body Giant Cells

    The primary objective is to assess the difference in Foreign Body Giant Cells between monofocal and toric lenses in every patient at 6 weeks follow up.

    Time frame: 6 weeks

Secondary outcomes

  1. Foreign Body Giant Cells

    The first secondary objective is to assess the difference in Foreign Body Giant Cells between monofocal and toric lenses in every patient at 1 week and 5 months follow up.

    Time frame: 5 months

  2. small round cells

    The second secondary objective is to assess the difference in small round cells between monofocal and toric lenses in every patient at 1 week, 6 weeks and 5 months follow up.

    Time frame: 5 months

  3. PCO

    The third secondary objective is to assess the difference in PCO between monofocal and toric lenses in every patient at 1 week, 6 weeks and 5 months follow up.

    Time frame: 5 months

  4. anterior chamber reaction

    The fourth secondary objective is to assess the difference in the anterior chamber reaction between monofocal and toric lenses in every patient at 1 week, 6 weeks and 5 months follow up.

    Time frame: 5 months

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Study locations

1 site
  • Medical University of Vienna
    Vienna, 1090, Austria
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References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 27, 2024, 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
NCT06708806
Lead sponsor
Medical University of Vienna
Responsible party
Christina Leydolt (Assoc. Prof. Priv. Doz. Dr., Medical University of Vienna) — Principal investigator
First posted
Nov 27, 2024
Start date
Apr 7, 2021
Primary completion
Nov 11, 2022
Completion
Nov 11, 2022
Last update
Nov 27, 2024

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 completed, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.

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