CataractRCT_ICB00NCT06118944
Outcomes of Bilateral Implantation of an Enhanced Monofocal Intraocular Lens
A study testing ICB00 IOL, ZCB00 IOL and CNA0T0 IOL in people with Cataract, run by University of Trieste at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 99 years
- Conditions the study is for
- Cataract
- What is being tested?
- ICB00 IOL, ZCB00 IOL and CNA0T0 IOL
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteItaly
- Study dates
- 11 Nov 2019to 31 Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Italy1 site
University Eye Clinic of Trieste
Trieste, Friuli Venezia Giulia, 34100
About this study
Official title: 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.
Read the 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.
- Conditions
- Cataract
- Being tested
- ICB00 IOL, ZCB00 IOL, CNA0T0 IOL
- Keywords
- IOL, intermediate distance, cataract surgery, enhanced monofocal
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ICB00 IOLDevice
Also called TECNIS EYHANCE IOL
Bilateral implantation of ICB00 IOL
ZCB00 IOLDevice
Bilateral implantation of ZCB00 IOL
CNA0T0 IOLDevice
Bilateral implantation of CNA0T0 IOL
| Study group | Role | What they receive |
|---|---|---|
| ICB00 Group | Experimental | ICB00 IOL Receives: Device: ICB00 IOL |
| ZCB00 Group | Active comparator | ZCB00 IOL Receives: Device: ZCB00 IOL |
| CNA0T0 Group | Active comparator | CNA0T0 IOL Receives: Device: CNA0T0 IOL |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bino DCIVA
Binocular distance corrected intermediate visual acuity
Measured: 12 weeks after second eye surgery
Secondary outcomes (13)
Mono DCIVA
Monocular distance corrected intermediate visual acuity
Measured: 12 weeks after second eye surgery
Mono UIVA
Monocular uncorrected intermediate visual acuity
Measured: 12 weeks after second eye surgery
Bino UIVA
Binocular uncorrected intermediate visual acuity
Measured: 12 weeks after second eye surgery
Mono UDVA
Monocular uncorrected distance visual acuity
Measured: 12 weeks after second eye surgery
Bino UDVA
Binocular uncorrected distance visual acuity
Measured: 12 weeks after second eye surgery
Mono BCDVA
Monocular best corrected distance visual acuity
Measured: 12 weeks after second eye surgery
Bino BCDVA
Binocular best corrected distance visual acuity
Measured: 12 weeks after second eye surgery
Mono UNVA
Monocular uncorrected near visual acuity
Measured: 12 weeks after second eye surgery
Bino UNVA
Binocular uncorrected near visual acuity
Measured: 12 weeks after second eye surgery
Mono CNVA
Monocular corrected near visual acuity
Measured: 12 weeks after second eye surgery
Bino CNVA
Binocular corrected near visual acuity
Measured: 12 weeks after second eye surgery
Binocular defocus curves
Binocular defocus curves in photopic conditions (from -4 D up to +2.00 D)
Measured: 12 weeks after second eye surgery
Catquest 9SF score changes
Changes in Catquest 9SF score before and 3 months after surgery
Measured: preop and 12 weeks after second eye surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2023
- Study start11 Nov 2019
- Primary completion30 Sep 2022
- Study completion31 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for CataractStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Trieste
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daniele Tognetto, University of Trieste
- Investigators
- Daniele Tognetto, MD, Principal investigator, University of Trieste
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06118944
- Sponsor's protocol ID
- 202_2019
- Acronym
- RCT_ICB00
- Status last verified
- Oct 2023
- First submitted
- 31 Oct 2023
- Last updated
- 7 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 20039853Ribeiro 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.
PubMed 32126025
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Visual Outcomes of a New Monofocal Intraocular Lens With Modified Optical Profile: a Randomized Controlled Clinical Study
- ClinicalTrials.gov ID
- NCT06118944
- Acronym / sponsor ID
- RCT_ICB00 / 202_2019
- Conditions
- Cataract
- Keywords
- IOL, intermediate distance, cataract surgery, enhanced monofocal
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- University of TriesteUniversity, hospital or other
- Study start
- 11 Nov 2019 (actual)
- Primary completion
- 30 Sep 2022 (actual)
- Study completion
- 31 Jan 2023 (actual)
- First posted
- 7 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ICB00 Group | Experimental | Device: ICB00 IOLICB00 IOL |
| ZCB00 Group | Active comparator | Device: ZCB00 IOLZCB00 IOL |
| CNA0T0 Group | Active comparator | Device: CNA0T0 IOLCNA0T0 IOL |
Who may qualify
- Ages
- 50 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ICB00 IOLAlso: TECNIS EYHANCE IOLBilateral implantation of ICB00 IOL | Device | ICB00 Group |
| ZCB00 IOLBilateral implantation of ZCB00 IOL | Device | ZCB00 Group |
| CNA0T0 IOLBilateral implantation of CNA0T0 IOL | Device | CNA0T0 Group |
Primary outcome
Bino DCIVA
Time frame: 12 weeks after second eye surgery
Binocular distance corrected intermediate visual acuity
13 secondary outcomes
Mono DCIVA
Time frame: 12 weeks after second eye surgery
Mono UIVA
Time frame: 12 weeks after second eye surgery
Bino UIVA
Time frame: 12 weeks after second eye surgery
Mono UDVA
Time frame: 12 weeks after second eye surgery
Bino UDVA
Time frame: 12 weeks after second eye surgery
Mono BCDVA
Time frame: 12 weeks after second eye surgery
Bino BCDVA
Time frame: 12 weeks after second eye surgery
Mono UNVA
Time frame: 12 weeks after second eye surgery
Bino UNVA
Time frame: 12 weeks after second eye surgery
Mono CNVA
Time frame: 12 weeks after second eye surgery
Bino CNVA
Time frame: 12 weeks after second eye surgery
Binocular defocus curves
Time frame: 12 weeks after second eye surgery
Catquest 9SF score changes
Time frame: preop and 12 weeks after second eye surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2023.
- Background: PubMed 20039853Lundstrom 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.
- Background: PubMed 32126025Ribeiro 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniele Tognetto, MD principal investigator
University of Trieste
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ICB00 IOL, ZCB00 IOL and CNA0T0 IOL in people with Cataract, run by University of Trieste at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bino DCIVA (time frame: 12 weeks after second eye surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06118944, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2023.