Prospective Evaluation of an Hydrophilic Acrylic Intraocular Lens

Cataract Senile Clinical Trial

— UVEA 809  

Official title:

Prospective Evaluation of the Clinical Safety and Effectiveness of Hydrophilic Acrylic Intraocular Lens

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04907500
• Other study ID #: LISA 809 BER-401-20
• Status: Completed
• Phase: N/A
• Start date: June 22, 2021
• Est. completion date: December 16, 2022

Study information

• Verified date: February 2023
• Source: Carl Zeiss Meditec AG
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Evaluation of the clinical safety and effectiveness of an hydrophilic acrylic intraocular lens

Description:

To show safety and the effectiveness in regard to the monocular corrected distance visual acuity (CDVA) and the distance-corrected near visual acuity (DCNVA) at 6 months postoperative.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 387
• Est. completion date: December 16, 2022
• Est. primary completion date: August 6, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Patients of any gender, aged 18 years or older

2. Patient is planned for aged-related cataract surgery and implantation of the study IOL into the capsular bag in at least one eye

3. Patient is willing and capable of providing informed consent

4. Patient is willing and capable of complying with visits and procedures as defined by this protocol

Exclusion Criteria:

1. Preoperative corrected distance visual acuity (CDVA) better than 0.3 logMAR (0.5 decimal)

2. Endothelial cell count of less than 2000/mm2

3. Ocular disorder that could potentially cause a clinically significant future visual acuity loss

4. Preoperative corneal astigmatism ative corneal to be < 1 D.

5. Clinically significant anterior segment pathology (e.g. chronic uveitis, iritis, aniridia, rubeosis iridis, anterior membrane dystrophies, poor pupil dilation, etc.)

6. Clinically significant abnormal corneal finding (e.g. keratoconus, pellucid marginal degeneration, or irregular astigmatism, clinically significant corneal membrane dystrophies)

7. Any clinically significant condition that could affect IOL stability (e.g. zonular dialysis, evident zonular weakness or dehiscence, etc.)

8. Any History of clinically significant retinal pathologies or ocular diagnosis (e.g. diabetic retinopathy, ischemic diseases, macular degeneration, retinal detachment, optic neuropathy optic nerve atrophy, amblyopia, strabismus, microphthalmos, aniridia, epiretinal membrane etc.) that could alter or limit final postoperative visual prognosis

9. Any acute infection (acute ocular disease, external/internal infection, systemic infection)

10. Any previous intraocular and corneal surgery

11. Uncontrolled glaucoma or IOP higher than 24mmHg under ocular hypertension treatment

12. Current systemic or ocular pharmacotherapy that effects patients'vision

13. Current pathology or condition that could be a risk for the patient according to the investigator opinion

14. Women during pregnancy and/or lactation

15. Patients unable to meet the limitations of the protocol or likely of noncooperation during the trial

16. Patients whose freedom is impaired by administrative or legal order

17. Subject is enrolled in any other concurrent clinical study, with the exception of local mandatory governmental registries and observational studies/registries, that do not affect patients'vision

Related Conditions & MeSH terms

• Cataract
• Cataract Senile

Intervention

Device:
• Intraocular lens
Cataract surgery

Locations

Country	Name	City	State
Romania	DUO STIL SRL , Clinica Oftalmologica Medoptic	Suceava

Sponsors (1)

Lead Sponsor	Collaborator
Carl Zeiss Meditec AG

Country where clinical trial is conducted

Romania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Monocular corrected distance visual acuity (CDVA)	Monocular corrected distance visual acuity measured in logMAR	6 months after the implantation