Lens OpacitiesNCT05704686
Clinical Outcomes of an New EDOF IOL (Isopure®)
An observational study of Lens Opacities and Cataract, run by Kristof Vandekerckhove, MD, MBA at 1 site in Switzerland.
Trial summary
Single-center, retrospective, open-label observational study aiming to evaluate visual outcomes and patient satisfaction after bilateral implantation of Isopure® EDOF-IOL with a mono-minovision target. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Lens Opacities, Cataract, Pseudophakia
- What is being tested?
- Isopure 1.2.3 intraocular EDOF lens implantation
- Type of treatment
- Medical device
- How many people
- 62 participants
- Where
- 1 siteSwitzerland
- Study dates
- 26 Apr 2021to 31 Dec 2021
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Consecutive patients undergoing routine cataract surgery and having opted for the implantation of an EDOF intraocular lens, in a primary ophthalmic clinic in Switzerland.
Who may be able to join
- Male or female patients aged 50 years or older undergoing a routine cataract surgery and benefiting from bilateral IOL implantation with Isopure 1.2.3 IOL;
- Patient's willingness to participate in the study;
- Capacity to understand and sign an informed consent form and comply with examination procedures;
- Cataractous eyes with no vision-impacting comorbidity (estimated visual potential post-surgery 0.2 logMAR or better);
- Regular total corneal astigmatism ≤1.5 D (measured by topography method)
Who cannot join
- Cooperation difficulties (distance from home, general health conditions, cognitive impairment);
- Subjects with diagnosed extra- or intraocular vision-affecting comorbidities (macular degeneration, glaucoma or other retinal or optic nerve disorders, previous ocular surgeries, amblyopia);
- Patients who previously benefitted from refractive surgery (PRK/LASIK) were included if no refractive surgery-related complications were noted (i.e: ectasia, corneal haze, dry eye);
- History or presence of macular edema;
- Perioperative complications;
- Congenital, uveitic, traumatic or surgically-complicated cataract
- Regular total corneal astigmatism >1.5 dioptres (measured by topography method)
- Irregular cornea, including keratotomy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Visual Outcomes and Patient Satisfaction After the Implantation of Isopure Extended-Depth-of-Focus Intraocular Lens (EDOF-IOL), With a Mini-Monovision Target
Single-center, retrospective, open-label observational study aiming to evaluate visual outcomes and patient satisfaction after bilateral implantation of Isopure® EDOF-IOL with a mono-minovision target.
Read the detailed description
This single-center retrospective study investigates visual outcomes and patient satisfaction in subjects bilaterally implanted with Enhanced-Depth of Focus (EDOF) Isopure® IOL during routine bilateral cataract surgery.
The study is carried out in an ophthalmic clinic in Switzerland. In this study, routine surgical techniques and postoperative follow-up will be applied as for all other (non-study) cataract patients in the clinic. Therefore, all study patients will be operated in immediate consecutive bilateral mode (routine in clinic). Patients participating in this study will be recruited and enrolled postoperatively. They undergo routine postoperative follow-up examinations, and data are collected at the third scheduled examination (4 to 6 weeks after surgery) and at a telephone call 4 to 6 months after surgery.
Isopure 1.2.3 is a CE certified intraocular lens readily available on the market in Switzerland.
The primary outcome consists in demonstrating a preserved distance visual acuity while improving binocular spectacle-free intermediate vision and, to a lesser extent, near vision. Binocular defocus curves are measured for each participant to simulate visual acuity at different distances. Patient satisfaction with treatment and subjective ratings of visual phenomena will be assessed using a modified PRISQ questionnaire and a modified NEI quality of vision questionnaire (RQL-42) at the third postoperative visit and three months after surgery.
At Vista Alpina Eye Clinic, mini-monovision is routinely used to further improve binocular intermediate and near vision while preserving the quality of distance vision in patients implanted bilaterally with EDOF Isopure® IOLs. Analysis of the retrospective data should help support this surgical strategy.
Patients with astigmatism up to 1.5 D benefit intraoperatively from Opposite Clear Corneal Incisions (OCCI) to reduce astigmatism. Analysis of our retrospective data will allow comparison of their visual performance with that of patients without astigmatism who did not require an additional OCCI procedure.
- Conditions
- Lens Opacities, Cataract, Pseudophakia
- Being tested
- Isopure 1.2.3 intraocular EDOF lens implantation
- Medical subject headings
- Cataract, Pseudophakia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Isopure 1.2.3 intraocular EDOF lens implantationDevice
Bilateral Isopure 1.2.3 intraocular EDOF IOL implantation during a routine cataract surgery.
What is being measured
The primary outcome is the main question the study is designed to answer.
UDVA(m)
Monocular Uncorrected Distance Visual Acuity
Measured: 4-6 weeks postoperatively
CDVA(m)
Monocular Corrected Distance Visual Acuity
Measured: 4-6 weeks postoperatively
UDVA(b)
Binocular Uncorrected Distance Visual Acuity
Measured: 4-6 weeks postoperatively
UIVA
Binocular Uncorrected Intermediate Visual Acuity (80 cm)
Measured: 4-6 weeks postoperatively
UNVA
Binocular Uncorrected Near Visual Acuity (40 cm)
Measured: 4-6 weeks postoperatively
Defocus curve
Binocular distance-corrected defocus curve analysis simulating visual acuities at different distances.
Measured: 4-6 weeks postoperatively
Secondary outcomes (2)
Patient satisfaction with the visual outcome
(modified) PRISQ questionnaire
Measured: 4-6 weeks postoperatively and 4-6 months postoperatively
Subjective rating of visual phenomena
(modified) NEI quality of vision questionnaire (RQL-42, questions 17 and 38)
Measured: 4-6 weeks postoperatively and 4-6 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2023
- Study start26 Apr 2021
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lens OpacitiesStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kristof Vandekerckhove, MD, MBA
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Kristof Vandekerckhove, MD, MBA, Vista Alpina Eye Clinic
- Investigators
- Kristof Vandekerckhove, MD, Principal investigator, Vista Alpina Eye Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05704686
- Sponsor's protocol ID
- Iso123
- Status last verified
- Jan 2023
- First submitted
- 19 Jan 2023
- Last updated
- 30 Jan 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Visual Outcomes and Patient Satisfaction After the Implantation of Isopure Extended-Depth-of-Focus Intraocular Lens (EDOF-IOL), With a Mini-Monovision Target
- ClinicalTrials.gov ID
- NCT05704686
- Acronym / sponsor ID
- Iso123
- Conditions
- Lens Opacities, Cataract, Pseudophakia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Kristof Vandekerckhove, MD, MBAUniversity, hospital or other
- Study start
- 26 Apr 2021 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 30 Jan 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.
Single-center, retrospective, open-label observational study aiming to evaluate visual outcomes and patient satisfaction after bilateral implantation of Isopure® EDOF-IOL with a mono-minovision target.
Detailed description
This single-center retrospective study investigates visual outcomes and patient satisfaction in subjects bilaterally implanted with Enhanced-Depth of Focus (EDOF) Isopure® IOL during routine bilateral cataract surgery.
The study is carried out in an ophthalmic clinic in Switzerland. In this study, routine surgical techniques and postoperative follow-up will be applied as for all other (non-study) cataract patients in the clinic. Therefore, all study patients will be operated in immediate consecutive bilateral mode (routine in clinic). Patients participating in this study will be recruited and enrolled postoperatively. They undergo routine postoperative follow-up examinations, and data are collected at the third scheduled examination (4 to 6 weeks after surgery) and at a telephone call 4 to 6 months after surgery.
Isopure 1.2.3 is a CE certified intraocular lens readily available on the market in Switzerland.
The primary outcome consists in demonstrating a preserved distance visual acuity while improving binocular spectacle-free intermediate vision and, to a lesser extent, near vision. Binocular defocus curves are measured for each participant to simulate visual acuity at different distances. Patient satisfaction with treatment and subjective ratings of visual phenomena will be assessed using a modified PRISQ questionnaire and a modified NEI quality of vision questionnaire (RQL-42) at the third postoperative visit and three months after surgery.
At Vista Alpina Eye Clinic, mini-monovision is routinely used to further improve binocular intermediate and near vision while preserving the quality of distance vision in patients implanted bilaterally with EDOF Isopure® IOLs. Analysis of the retrospective data should help support this surgical strategy.
Patients with astigmatism up to 1.5 D benefit intraoperatively from Opposite Clear Corneal Incisions (OCCI) to reduce astigmatism. Analysis of our retrospective data will allow comparison of their visual performance with that of patients without astigmatism who did not require an additional OCCI procedure.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive patients undergoing routine cataract surgery and having opted for the implantation of an EDOF intraocular lens, in a primary ophthalmic clinic in Switzerland.
Key inclusion criteria (5 listed)
- Male or female patients aged 50 years or older undergoing a routine cataract surgery and benefiting from bilateral IOL implantation with Isopure 1.2.3 IOL;
- Patient's willingness to participate in the study;
- Capacity to understand and sign an informed consent form and comply with examination procedures;
- Cataractous eyes with no vision-impacting comorbidity (estimated visual potential post-surgery 0.2 logMAR or better);
- Regular total corneal astigmatism ≤1.5 D (measured by topography method)
Key exclusion criteria (8 listed)
- Cooperation difficulties (distance from home, general health conditions, cognitive impairment);
- Subjects with diagnosed extra- or intraocular vision-affecting comorbidities (macular degeneration, glaucoma or other retinal or optic nerve disorders, previous ocular surgeries, amblyopia);
- Patients who previously benefitted from refractive surgery (PRK/LASIK) were included if no refractive surgery-related complications were noted (i.e: ectasia, corneal haze, dry eye);
- History or presence of macular edema;
- Perioperative complications;
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 |
|---|---|---|
| Isopure 1.2.3 intraocular EDOF lens implantationBilateral Isopure 1.2.3 intraocular EDOF IOL implantation during a routine cataract surgery. | Device | – |
Primary outcome
UDVA(m)
Time frame: 4-6 weeks postoperatively
Monocular Uncorrected Distance Visual Acuity
CDVA(m)
Time frame: 4-6 weeks postoperatively
Monocular Corrected Distance Visual Acuity
UDVA(b)
Time frame: 4-6 weeks postoperatively
Binocular Uncorrected Distance Visual Acuity
UIVA
Time frame: 4-6 weeks postoperatively
Binocular Uncorrected Intermediate Visual Acuity (80 cm)
UNVA
Time frame: 4-6 weeks postoperatively
Binocular Uncorrected Near Visual Acuity (40 cm)
Defocus curve
Time frame: 4-6 weeks postoperatively
Binocular distance-corrected defocus curve analysis simulating visual acuities at different distances.
2 secondary outcomes
Patient satisfaction with the visual outcome
Time frame: 4-6 weeks postoperatively and 4-6 months postoperatively
Subjective rating of visual phenomena
Time frame: 4-6 weeks postoperatively and 4-6 months postoperatively
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 30 Jan 2023.
- 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.
Kristof Vandekerckhove, MD principal investigator
Vista Alpina Eye Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lens Opacities and Cataract, run by Kristof Vandekerckhove, MD, MBA at 1 site in Switzerland.
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 8 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 30 Jan 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 Switzerland. 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?
UDVA(m) (time frame: 4-6 weeks postoperatively). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Jan 2023.