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Evaluation of Physiological Responses at the Anterior Surface of Two (Hydrophobic Acrylic) Intraocular Lens Models

Not Applicable
Conditions
Age Related Cataracts
Interventions
Device: Vivinex XY1
Device: Vivinex XY1A
Registration Number
NCT04230629
Lead Sponsor
Medical University of Vienna
Brief Summary

On the day of surgery, the the eye with astigmatism of at least 0.75dpt receives a Vivinex XY1A , HOYA Surgical Optics GmbH and the second eye to be operated receives an XY1, HOYA Surgical Optics GmbH.

A complete biomicroscopic examination and visual acuity testing using autorefractometer, will be performed 1 week (7-14days), 6 weeks (30-60days) and 5 month (4-6months) postoperatively.

Detailed Description

Not available

Recruitment & Eligibility

Status
UNKNOWN
Sex
All
Target Recruitment
50
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
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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

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Vivinex XY1Vivinex XY1Implantation of an intraocular lens Hoya Vivinex XY1
Vivinex XY1AVivinex XY1AImplantation of an intraocular lens Hoya Vivinex XY1A
Primary Outcome Measures
NameTimeMethod
Number of FBGC (foreign body giant cells) (slitlamp examination)5 months

The number of foreign body giant cells on the IOLs will be assessed.

Secondary Outcome Measures
NameTimeMethod
Incidence of Monocytes (slitlamp examination)5 months

The number of monocytes on the IOLs will be assessed. The following classification will be used: + = fewer than 10 cells/mm2; ++ = 10 to 25 cells/mm2; +++ = more than 25 cells/mm2

Grade of Anterior Fibrosis (slitlamp examination)5 months

Grade of anterior fibrosis assessed subjectively at the slitlamp (grade 0=no fibrosis, grade 3=maximum fibrosis)

PCO Score (slitlamp examination)5 months

Incidence and development of posterior capsular opacification will be subjectively graded: 0-10 (0= no PCO, 10= maximum PCO)

Anterior chamber reaction (slitlamp examination)5 months

Incidence of cells and tyndall in the anterior chamber (ratet as - to +++ respectively)

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