An observational study to evaluate safety and effectiveness of hydrophilic acrylic intraocular lens.

Not Applicable

• Conditions: Health Condition 1: H259- Unspecified age-related cataract

• Registration Number: CTRI/2021/11/037924
• Lead Sponsor: Carl Zeiss Meditec AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 17 October 2022

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 0

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 � 1 D or preoperative corneal

astigmatism � 1.5 D, if postoperative corneal astigmatism is not estimated

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 patientsââ?¬• 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 patientsââ?¬• vision

Note All eye-related inclusion and exclusion criteria are applicable to the study eye only.

If the non-study eye does not fulfil all criteria, the patient can still be enrolled into

the study.

Study & Design

• Study Type: Observational
• Study Design: Not specified