Vitreous DisorderLARANCT05427526
Outcome of Zeiss AT LARA EDOF Lens Implantation in Vitrectomized Eyes
A study testing intraocular lens implantation in people with Vitreous Disorder and Cataract, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial summary
To determine the surgical outcome and patient satisfaction in patients who underwent AT LARA lens implantation during or after vitrectomy at a relatively young age (around 55 years of age), mostly to treat (urgent) retinal detachment. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Vitreous Disorder, Cataract
- What is being tested?
- intraocular lens implantation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteBelgium
- Study dates
- 14 Feb 2022to 17 Aug 2022
- 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- patients that had a LARA IOL implanted in combination with vitrectomy.
- patients that had a LARA IOL implanted in during surgery for cataract secondary to vitrectomy.
Who cannot join
- Patients with a LARA IOL implanted without concomitant or earlier vitrectomy
Trial locations and contacts
1 site in 1 country.
About this study
To determine the surgical outcome and patient satisfaction in patients who underwent AT LARA lens implantation during or after vitrectomy at a relatively young age (around 55 years of age), mostly to treat (urgent) retinal detachment.
Read the detailed description
The surgical outcome is defined as the patient satisfaction determined by patient questionnaires.
- Visual quality: CatQuest questionnaire
- Near vision: NAVS questionnaire
- Glare: APPLES questionnaire
These questionnaires are standardized and validated, although no cut-off values have been determined. Hence, the results drawn from these questionnaires are descriptive only.
- Conditions
- Vitreous Disorder, Cataract
- Being tested
- intraocular lens implantation
- Keywords
- LARA EDOF lens, Intra ocular lensimplantation, cataract, vitrectomy
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intraocular lens implantationProcedure or surgery
Lens surgery during or before vitrectomy surgery.
| Study group | Role | What they receive |
|---|---|---|
| group 1: LARA IOL implanted in combination with vitrectomy. | Active comparator | intraocular lens implantation in combination with vitrectomy Receives: Procedure: intraocular lens implantation |
| group 2: LARA IOL implanted in during surgery for cataract secondary to vitrectomy | Active comparator | intraocular lens implantation during surgery for cataract secondary to vitrectomy Receives: Procedure: intraocular lens implantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
visual quality
Catquest questionnaire measuring activity limitations in daily life due to poor vision
Measured: 2 weeks
near vision
Near Activity Visual Questionnaire (NAVQ) evaluating the near vision
Measured: 2 weeks
glare
The Assessment of Photic Phenomena and Lens Effects (APPLES) questionnaire assessing the glare
Measured: 2 weeks
Secondary outcomes (1)
Binocular performance
visual acuity
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2022
- Study start14 Feb 2022
- Primary completion17 Aug 2022
- Study completion17 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vitreous DisorderStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- group 1: patients that had a LARA IOL implanted in combination with vitrectomy group 2: patients that had a LARA IOL implanted in during surgery for cataract secondary to vitrectomy
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Peter Stalmans, PhD, Principal investigator, UZ Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05427526
- Sponsor's protocol ID
- S65356
- Acronym
- LARA
- Status last verified
- Aug 2022
- First submitted
- 26 Jan 2022
- Last updated
- 26 Aug 2022
- Results posted
- No
- Data monitoring committee
- 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 26 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcome of Zeiss AT LARA EDOF Lens Implantation in Vitrectomized Eyes
- ClinicalTrials.gov ID
- NCT05427526
- Acronym / sponsor ID
- LARA / S65356
- Conditions
- Vitreous Disorder, Cataract
- Keywords
- LARA EDOF lens, Intra ocular lensimplantation, cataract, vitrectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- 14 Feb 2022 (actual)
- Primary completion
- 17 Aug 2022 (actual)
- Study completion
- 17 Aug 2022 (actual)
- First posted
- 22 Jun 2022 (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 determine the surgical outcome and patient satisfaction in patients who underwent AT LARA lens implantation during or after vitrectomy at a relatively young age (around 55 years of age), mostly to treat (urgent) retinal detachment.
Detailed description
The surgical outcome is defined as the patient satisfaction determined by patient questionnaires.
- Visual quality: CatQuest questionnaire
- Near vision: NAVS questionnaire
- Glare: APPLES questionnaire
These questionnaires are standardized and validated, although no cut-off values have been determined. Hence, the results drawn from these questionnaires are descriptive only.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- group 1: patients that had a LARA IOL implanted in combination with vitrectomy group 2: patients that had a LARA IOL implanted in during surgery for cataract secondary to vitrectomy
| Arm | Type | Receives |
|---|---|---|
| group 1: LARA IOL implanted in combination with vitrectomy. | Active comparator | Procedure: intraocular lens implantationintraocular lens implantation in combination with vitrectomy |
| group 2: LARA IOL implanted in during surgery for cataract secondary to vitrectomy | Active comparator | Procedure: intraocular lens implantationintraocular lens implantation during surgery for cataract secondary to vitrectomy |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- patients that had a LARA IOL implanted in combination with vitrectomy.
- patients that had a LARA IOL implanted in during surgery for cataract secondary to vitrectomy.
Key exclusion criteria (1 listed)
- Patients with a LARA IOL implanted without concomitant or earlier vitrectomy
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 |
|---|---|---|
| intraocular lens implantationLens surgery during or before vitrectomy surgery. | Procedure or surgery | group 1: LARA IOL implanted in combination with vitrectomy., group 2: LARA IOL implanted in during surgery for cataract secondary to vitrectomy |
Primary outcome
visual quality
Time frame: 2 weeks
Catquest questionnaire measuring activity limitations in daily life due to poor vision
near vision
Time frame: 2 weeks
Near Activity Visual Questionnaire (NAVQ) evaluating the near vision
glare
Time frame: 2 weeks
The Assessment of Photic Phenomena and Lens Effects (APPLES) questionnaire assessing the glare
1 secondary outcome
Binocular performance
Time frame: 2 weeks
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 26 Aug 2022.
- 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.
Peter Stalmans, PhD principal investigator
UZ Leuven
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing intraocular lens implantation in people with Vitreous Disorder and Cataract, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
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 2 inclusion and 1 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 26 Aug 2022. 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 Belgium. 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?
visual quality (time frame: 2 weeks). The study lists 3 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 26 Aug 2022.