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

Age Related Cataracts Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04230629
• Other study ID #: 2060/2019
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 15, 2021
• Est. completion date: June 30, 2022

Study information

• Verified date: March 2021
• Source: Medical University of Vienna
• Contact: Rupert Menapace
• Phone: 0140400
• Email: rupert.menapace[@]meduniwien.ac.at
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: June 30, 2022
• Est. primary completion date: December 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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:

• 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

Related Conditions & MeSH terms

• Age Related Cataracts
• Cataract

Intervention

Device:
• Vivinex XY1
Implantation of an intraocular lens Hoya Vivinex XY1
• Vivinex XY1A
Implantation of an intraocular lens Hoya Vivinex XY1A

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Vienna

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of FBGC (foreign body giant cells) (slitlamp examination)	The number of foreign body giant cells on the IOLs will be assessed.	5 months
Secondary	Incidence of Monocytes (slitlamp examination)	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	5 months
Secondary	PCO Score (slitlamp examination)	Incidence and development of posterior capsular opacification will be subjectively graded: 0-10 (0= no PCO, 10= maximum PCO)	5 months
Secondary	Grade of Anterior Fibrosis (slitlamp examination)	Grade of anterior fibrosis assessed subjectively at the slitlamp (grade 0=no fibrosis, grade 3=maximum fibrosis)	5 months
Secondary	Anterior chamber reaction (slitlamp examination)	Incidence of cells and tyndall in the anterior chamber (ratet as - to +++ respectively)	5 months