Clinical trial NCT06118944: Outcomes of Bilateral Implantation of an Enhanced Monofocal Intraocular Lens
Official title: Visual Outcomes of a New Monofocal Intraocular Lens With Modified Optical Profile: a Randomized Controlled Clinical Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cataract
Keywords: IOL
intermediate distance
cataract surgery
enhanced monofocal
Lead sponsor: University of Trieste
Sponsor class: OTHER
First posted: 2023-11-07
Enrollment: 90
Sex: ALL
Minimum age (years): 50
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Bino DCIVA
timeFrame: 12 weeks after second eye surgery
Secondary outcomes:
measure: Mono DCIVA
timeFrame: 12 weeks after second eye surgery
measure: Mono UIVA
timeFrame: 12 weeks after second eye surgery
measure: Bino UIVA
timeFrame: 12 weeks after second eye surgery
measure: Mono UDVA
timeFrame: 12 weeks after second eye surgery
measure: Bino UDVA
timeFrame: 12 weeks after second eye surgery
measure: Mono BCDVA
timeFrame: 12 weeks after second eye surgery
measure: Bino BCDVA
timeFrame: 12 weeks after second eye surgery
measure: Mono UNVA
timeFrame: 12 weeks after second eye surgery
measure: Bino UNVA
timeFrame: 12 weeks after second eye surgery
measure: Mono CNVA
timeFrame: 12 weeks after second eye surgery
measure: Bino CNVA
timeFrame: 12 weeks after second eye surgery
measure: Binocular defocus curves
timeFrame: 12 weeks after second eye surgery
measure: Catquest 9SF score changes
timeFrame: preop and 12 weeks after second eye surgery
Other outcomes:
Locations:
city: Trieste
country: Italy
facility: University Eye Clinic of Trieste
state: Friuli Venezia Giulia
Study officials:
affiliation: University of Trieste
name: Daniele Tognetto, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lundstrom M, Behndig A, Kugelberg M, Montan P, Stenevi U, Pesudovs K. The outcome of cataract surgery measured with the Catquest-9SF. Acta Ophthalmol. 2011 Dec;89(8):718-23. doi: 10.1111/j.1755-3768.2009.01801.x. Epub 2009 Dec 21.
citation: Ribeiro F, Cochener B, Kohnen T, Mencucci R, Katz G, Lundstrom M, Casanovas AS, Hewlett D. Definition and clinical relevance of the concept of functional vision in cataract surgery ESCRS Position Statement on Intermediate Vision: ESCRS Functional Vision Working Group. J Cataract Refract Surg. 2020 Feb;46 Suppl 1:S1-S3. doi: 10.1097/j.jcrs.0000000000000096. No abstract available.