Outcomes of Bilateral Implantation of an Enhanced Monofocal Intraocular Lens

Visual Outcomes of a New Monofocal Intraocular Lens With Modified Optical Profile: a Randomized Controlled Clinical Study

To evaluate and compare the visual outcomes of an enhanced monofocal intraocular lens (IOL) with two different monofocal IOLs in patients scheduled for bilateral cataract surgery.

The main objective of the study is the evaluation and comparison of the clinical outcomes of three parallel groups of patients after bilateral implantation of ICB00 IOL or ZCB00 IOL or CNA0T0 IOL respectively.

The ICB00 IOL is a modified monofocal IOL. Compared to other monofocal IOLs, its modified optical design was created to provide improved intermediate vision, comparable distance vision and a profile of dysphotopsia similar to other monofocal lenses.

Considering the modified optical profile of the ICB00 IOL, the primary objective will be the evaluation of visual performance at intermediate distance.

Inclusion Criteria:

• clinically significant bilateral cataract (BCVA <20/40, cataract must be the primary cause of visual impairment)
• axial length between 21 and 27 mm
• the patient must be able to read, understand and provide written informed consent,
• the patient must be willing and able to comply with all study and follow-up procedures
• preoperative refractive cylinder ≤ 0.75 D

Exclusion Criteria:

• anterior segment pathology that could significantly affect results (e.g., chronic uveitis, iritis, corneal dystrophy, keratoconus)
• diabetic retinopathy
• uncontrolled glaucoma and/or intraocular pressure IOP> 24 mmHg
• all types of infections (acute eye disease, external/internal infection, systemic infection)
• traumatic cataract
• pupillary abnormalities including aniridia and/or pupil diameter in mesopic conditions in distance vision ≤ 2.5 mm and ≥ 6 mm
• microphthalmia
• amblyopia
• degenerative visual disorders (for example macular degeneration, optic nerve atrophy or retinal disorders)
• previous intraocular and corneal surgery
• systemic or ocular pharmacotherapy, which may impact visual acuity and/or cause floppy iris syndrome and/or insufficient dilation in the opinion of the investigator
• patients who are unable to fixate for a prolonged time (e.g. strabismus, nystagmus)
• period of pregnancy or breastfeeding for female patients