Outcomes of Bilateral Implantation of an Enhanced Monofocal Intraocular Lens
NCT ID: NCT06118944
Last Updated: 2023-11-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
90 participants
INTERVENTIONAL
2019-11-11
2023-01-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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ICB00 Group
ICB00 IOL
ICB00 IOL
Bilateral implantation of ICB00 IOL
ZCB00 Group
ZCB00 IOL
ZCB00 IOL
Bilateral implantation of ZCB00 IOL
CNA0T0 Group
CNA0T0 IOL
CNA0T0 IOL
Bilateral implantation of CNA0T0 IOL
Interventions
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ICB00 IOL
Bilateral implantation of ICB00 IOL
ZCB00 IOL
Bilateral implantation of ZCB00 IOL
CNA0T0 IOL
Bilateral implantation of CNA0T0 IOL
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
50 Years
99 Years
ALL
No
Sponsors
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University of Trieste
OTHER
Responsible Party
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Daniele Tognetto
Professor
Principal Investigators
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Daniele Tognetto, MD
Role: PRINCIPAL_INVESTIGATOR
University of Trieste
Locations
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University Eye Clinic of Trieste
Trieste, Friuli Venezia Giulia, Italy
Countries
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References
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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.
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.
Other Identifiers
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202_2019
Identifier Type: -
Identifier Source: org_study_id
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