CataractNCT06708806
Cell Ongrowth and Biocompatibility Study of Two Different (Hydrophobic Acrylic) Intraocular Lenses: IOL XY1 vs. IOL XY1A
A study testing cataract surgery in people with Cataract, run by Medical University of Vienna at 1 site in Austria.
Trial summary
The investigational devices are approved intraocular lenses (IOLs) intended to be implanted after phacoemulsification in individuals suffering from age-related cataract with the need of cataract surgery. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Cataract
- What is being tested?
- cataract surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteAustria
- Study dates
- 7 Apr 2021to 11 Nov 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Bilateral age-related cataract for which phacoemulsification extraction and posterior IOL implantation is planned
- Age 40 and older
- Astigmatism of at least 0.75Diopters in one eye
- Normal findings in medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant
Who cannot join
- Diabetes mellitus
- Pseudoexfoliation syndrome
- Systemical anticoagulation
- Antiphlogistic therapy
- Antiglaucomatosa
- Uncontrolled systemic or ocular disease
Show all 10Show fewer
- Preceding ocular surgery or trauma
- Intraoperative complications
- Pregnancy/Nursing
- Concurrently participating in any other clinical trial or if they have participated in any other clinical trial during the last 30 days
Trial locations and contacts
1 site in 1 country.
About this study
The investigational devices are approved intraocular lenses (IOLs) intended to be implanted after phacoemulsification in individuals suffering from age-related cataract with the need of cataract surgery. Cataract surgery with precedent bilateral randomized IOL implantation will be performed in subjects who have signed an informed consent form. Postoperative examinations will be implemented in accordance with the approved investigational plan.
- Conditions
- Cataract
- Being tested
- cataract surgery
- Keywords
- Biocompatibility
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cataract surgeryProcedure or surgery
bilateral cataract surgery including phacoemulsification in individuals suffering from age-related cataract and intraocular lens implantation of a monofocal IOL (XY1) vs. an toric IOL (XY1A)
| Study group | Role | What they receive |
|---|---|---|
| Toric vs Monofocal IOL | Other | The investigational devices are approved intraocular lenses (IOLs) intended to be implanted after phacoemulsification in individuals suffering from age-related cataract with the need of cataract surgery. In Arm one (I) participants will receive a monofocal IOL (XY1) vs. an toric IOL (XY1A) Receives: Procedure: cataract surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Foreign Body Giant Cells
The primary objective is to assess the difference in Foreign Body Giant Cells between monofocal and toric lenses in every patient at 6 weeks follow up.
Measured: 6 weeks
Secondary outcomes (4)
Foreign Body Giant Cells
The first secondary objective is to assess the difference in Foreign Body Giant Cells between monofocal and toric lenses in every patient at 1 week and 5 months follow up.
Measured: 5 months
small round cells
The second secondary objective is to assess the difference in small round cells between monofocal and toric lenses in every patient at 1 week, 6 weeks and 5 months follow up.
Measured: 5 months
PCO
The third secondary objective is to assess the difference in PCO between monofocal and toric lenses in every patient at 1 week, 6 weeks and 5 months follow up.
Measured: 5 months
anterior chamber reaction
The fourth secondary objective is to assess the difference in the anterior chamber reaction between monofocal and toric lenses in every patient at 1 week, 6 weeks and 5 months follow up.
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2024
- Study start7 Apr 2021
- Primary completion11 Nov 2022
- Study completion11 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CataractStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe 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
- Not applicable
- Intervention model
- Single group
- Model description
- Intra-individual comparison of the biocompatibility of two different IOLs. Investigated IOLs will be implanted subsequently according to the study protocol with one IOL type in the eye with no astigmatism and the other IOL type in the eye with astigmatism.
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christina Leydolt, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06708806
- Sponsor's protocol ID
- HOPP
- Other IDs
- 2060/2019
- Status last verified
- Nov 2024
- First submitted
- 26 Nov 2024
- Last updated
- 27 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cell Ongrowth and Biocompatibility Study of Two Different (Hydrophobic Acrylic) Intraocular Lenses: IOL XY1 vs. IOL XY1A
- ClinicalTrials.gov ID
- NCT06708806
- Acronym / sponsor ID
- HOPP
- Conditions
- Cataract
- Keywords
- Biocompatibility
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- 7 Apr 2021 (actual)
- Primary completion
- 11 Nov 2022 (actual)
- Study completion
- 11 Nov 2022 (actual)
- First posted
- 27 Nov 2024 (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.
The investigational devices are approved intraocular lenses (IOLs) intended to be implanted after phacoemulsification in individuals suffering from age-related cataract with the need of cataract surgery. Cataract surgery with precedent bilateral randomized IOL implantation will be performed in subjects who have signed an informed consent form. Postoperative examinations will be implemented in accordance with the approved investigational plan.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Intra-individual comparison of the biocompatibility of two different IOLs. Investigated IOLs will be implanted subsequently according to the study protocol with one IOL type in the eye with no astigmatism and the other IOL type in the eye with astigmatism.
| Arm | Type | Receives |
|---|---|---|
| Toric vs Monofocal IOL | Other | Procedure: cataract surgeryThe investigational devices are approved intraocular lenses (IOLs) intended to be implanted after phacoemulsification in individuals suffering from age-related cataract with the need of cataract surgery. In Arm one (I) participants will receive a monofocal IOL (XY1) vs. an toric IOL (XY1A) |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Bilateral age-related cataract for which phacoemulsification extraction and posterior IOL implantation is planned
- Age 40 and older
- Astigmatism of at least 0.75Diopters in one eye
- Normal findings in medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant
Key exclusion criteria (10 listed)
- Diabetes mellitus
- Pseudoexfoliation syndrome
- Systemical anticoagulation
- Antiphlogistic therapy
- Antiglaucomatosa
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 |
|---|---|---|
| cataract surgerybilateral cataract surgery including phacoemulsification in individuals suffering from age-related cataract and intraocular lens implantation of a monofocal IOL (XY1) vs. an toric IOL (XY1A) | Procedure or surgery | Toric vs Monofocal IOL |
Primary outcome
Foreign Body Giant Cells
Time frame: 6 weeks
The primary objective is to assess the difference in Foreign Body Giant Cells between monofocal and toric lenses in every patient at 6 weeks follow up.
4 secondary outcomes
Foreign Body Giant Cells
Time frame: 5 months
small round cells
Time frame: 5 months
PCO
Time frame: 5 months
anterior chamber reaction
Time frame: 5 months
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 27 Nov 2024.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cataract surgery in people with Cataract, run by Medical University of Vienna at 1 site in Austria.
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 4 inclusion and 10 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 27 Nov 2024. 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 Austria. 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?
Foreign Body Giant Cells (time frame: 6 weeks). 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 27 Nov 2024.