Evaluation of a Spherical Hydrophilic Acrylic Intraocular Lens

Cataract Senile Clinical Trial

Official title:

Retro-prospective Evaluation of the Clinical Safety and Effectiveness of Hydrophilic Acrylic Intraocular Lens

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04998409
• Other study ID #: SPHERIS 209 BER-401-20
• Status: Completed
• Start date: September 24, 2021
• Est. completion date: April 22, 2022

Study information

• Verified date: May 2022
• Source: Carl Zeiss Meditec AG
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Description:

To show safety and the effectiveness in regard to the monocular corrected distance visual acuity (CDVA) at 12-24 month postoperative.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 242
• Est. completion date: April 22, 2022
• Est. primary completion date: April 22, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients of any gender, aged 18 years or older at the time of the surgery

• Patients who had an uncomplicated (no intra-operative complication) aged-related cataract surgery

• Currently implanted with the study IOL into the capsular bag in at least one eye

• One-year post surgery follow-up (365 days -14 days/+365 days) for the study eye at the time of the postoperative visit

• Patient is willing and capable of providing informed consent

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

Exclusion Criteria:

• Preoperative corrected distance visual acuity (CDVA) better than 0.3 LogMAR (0.5 decimal) or CDVA not available preoperatively

• Preoperative documented endothelial cell count of less than 2000/mm2 (if available)

• Any preoperative documented ocular disorder that could potentially cause a clinically significant future visual acuity loss

• Any preoperative documented clinically significant anterior segment pathology (e.g. chronic uveitis, iritis, aniridia, rubeosis iridis, anterior membrane dystrophies, poor pupil dilation, etc.)

• Any preoperative documented clinically significant abnormal corneal finding (e.g. keratoconus, pellucid marginal degeneration, or irregular astigmatism, clinically significant corneal membrane dystrophies)

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

• Any preoperative documented 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

• Any preoperative acute infection (acute ocular disease, external/internal infection, systemic infection)

• Any previous preoperative intraocular and corneal surgery

• Preoperative documented uncontrolled glaucoma or IOP higher than 24mmHg under ocular hypertension treatment

• Preoperative documented or current systemic or ocular pharmacotherapy that effects patients' vision

• Any other preoperative documented or current pathology or condition that could be a risk for the patient according to the investigator opinion

• Women during pregnancy and/or lactation at time of enrollment into the study

• Patients unable to meet the limitations of the protocol or likely of non-cooperation during the trial

• Patients whose freedom is impaired by administrative or legal order

• 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:
• Monofocal lens
not applicable as patients are already implanted with the monofocal lens

Locations

Country	Name	City	State
Germany	Augenklinik Rosenheim	Rosenheim

Sponsors (1)

Lead Sponsor	Collaborator
Carl Zeiss Meditec AG

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual acuity	Monocular visual acuity at far distance (4m) using sloan letters	12 to 24 months after the implantation