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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ICB00 Group | Experimental | ICB00 IOL |
|
| ZCB00 Group | Active Comparator | ZCB00 IOL |
|
| CNA0T0 Group | Active Comparator | CNA0T0 IOL |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ICB00 IOL | Device | Bilateral implantation of ICB00 IOL |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Bino DCIVA | Binocular distance corrected intermediate visual acuity | 12 weeks after second eye surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Mono DCIVA | Monocular distance corrected intermediate visual acuity | 12 weeks after second eye surgery |
| Mono UIVA | Monocular uncorrected intermediate visual acuity |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Daniele Tognetto, MD | University of Trieste | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Eye Clinic of Trieste | Trieste | Friuli Venezia Giulia | 34100 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20039853 | Background | 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. | |
| 32126025 | Background | 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. |
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| ID | Term |
|---|---|
| D002386 | Cataract |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
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| ZCB00 IOL | Device | Bilateral implantation of ZCB00 IOL |
|
| CNA0T0 IOL | Device | Bilateral implantation of CNA0T0 IOL |
|
| 12 weeks after second eye surgery |
| Bino UIVA | Binocular uncorrected intermediate visual acuity | 12 weeks after second eye surgery |
| Mono UDVA | Monocular uncorrected distance visual acuity | 12 weeks after second eye surgery |
| Bino UDVA | Binocular uncorrected distance visual acuity | 12 weeks after second eye surgery |
| Mono BCDVA | Monocular best corrected distance visual acuity | 12 weeks after second eye surgery |
| Bino BCDVA | Binocular best corrected distance visual acuity | 12 weeks after second eye surgery |
| Mono UNVA | Monocular uncorrected near visual acuity | 12 weeks after second eye surgery |
| Bino UNVA | Binocular uncorrected near visual acuity | 12 weeks after second eye surgery |
| Mono CNVA | Monocular corrected near visual acuity | 12 weeks after second eye surgery |
| Bino CNVA | Binocular corrected near visual acuity | 12 weeks after second eye surgery |
| Binocular defocus curves | Binocular defocus curves in photopic conditions (from -4 D up to +2.00 D) | 12 weeks after second eye surgery |
| Catquest 9SF score changes | Changes in Catquest 9SF score before and 3 months after surgery | preop and 12 weeks after second eye surgery |