Intraocular Lens ComplicationNCT06294405
Intraocular Lens Implant Registry Study
An observational study of Intraocular Lens Complication and Intraocular Lens Rotation, run by University Hospital Augsburg at 1 site in Germany.
Trial summary
The goal of this registry study is to optimize the results with intraocular lens implants used in cataract surgery. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Intraocular Lens Complication, Intraocular Lens Rotation, Intraocular Lens Associated Postoperative Inflammation
- What is being tested?
- Intraocular lens Implantation
- Type of treatment
- Medical device
- How many people
- 500 participants
- Where
- 1 siteGermany
- Study dates
- 21 Feb 2024to 14 Feb 2029
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients who receive an intraocular lens are offered to participate in the study.
Who may be able to join
- Treatment with an intraocular lens implant 18 years of age or older Patient consent Full legal capacity
Who cannot join
- Dementia Pregnancy Breastfeeding
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
University Hospital Augsburg
Augsburg
Isabella Baur, MD
About this study
Official title: Development of a Database to Optimize the Results With Intraocular Lens Implants
The goal of this registry study is to optimize the results with intraocular lens implants used in cataract surgery.
Read the detailed description
A variety of intraocular lens implants are available for patients undergoing cataract surgery and new technologies are continuously being developed in this field.
In the planned monocentric retro- and prospective clinical study, a database to optimize outcomes with modern intraocular lens implants will be established to further improve anatomical and functional outcomes.
Patients treated with an intraocular lens implant will be included. The retrospective evaluation of data includes data routinely collected prior to study inclusion (preoperative, intraoperative, postoperative up to the 1st study visit). Prospectively, refraction, visual acuity, examination findings, intraocular pressure and complications are recorded 1-6 months postoperatively. Depending on the type of IOL, results of further non-invasive measurements are also recorded. Optional follow-up visits with the aforementioned examinations are possible up to 10 years postoperatively.
- Conditions
- Intraocular Lens Complication, Intraocular Lens Rotation, Intraocular Lens Associated Postoperative Inflammation, Lens Opacities
- Being tested
- Intraocular lens Implantation
- 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 ImplantationDevice
Intraocular lenses are implanted during cataract surgery to replace the human crystalline lens.
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional results with different Intraocular lenses
Visual acuity with different intraocular lenses is determined.
Measured: 6 months
Contrast sestivitiy with different Intraocular lenses
Contrast sensitivity with different intraocular lenses is determined.
Measured: 6 months
Anatomical results.
Anatomical results with different intraocular lenses are determined.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2024
- Study start21 Feb 2024
- Primary completion14 Feb 2029 (estimated)
- Study completion14 Feb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intraocular Lens ComplicationStudies 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
- Other
- Time perspective
- Other
- Enrolment
- 500 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- University Hospital Augsburg
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. med.Isabella Baur, University Hospital Augsburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06294405
- Sponsor's protocol ID
- 24-0010
- Status last verified
- Mar 2024
- First submitted
- 20 Feb 2024
- Last updated
- 5 Mar 2024
- 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 5 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Database to Optimize the Results With Intraocular Lens Implants
- ClinicalTrials.gov ID
- NCT06294405
- Acronym / sponsor ID
- 24-0010
- Conditions
- Intraocular Lens Complication, Intraocular Lens Rotation, Intraocular Lens Associated Postoperative Inflammation, Lens Opacities
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- University Hospital AugsburgUniversity, hospital or other
- Study start
- 21 Feb 2024 (actual)
- Primary completion
- 14 Feb 2029 (estimated)
- Study completion
- 14 Feb 2029 (estimated)
- First posted
- 5 Mar 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 goal of this registry study is to optimize the results with intraocular lens implants used in cataract surgery.
Detailed description
A variety of intraocular lens implants are available for patients undergoing cataract surgery and new technologies are continuously being developed in this field.
In the planned monocentric retro- and prospective clinical study, a database to optimize outcomes with modern intraocular lens implants will be established to further improve anatomical and functional outcomes.
Patients treated with an intraocular lens implant will be included. The retrospective evaluation of data includes data routinely collected prior to study inclusion (preoperative, intraoperative, postoperative up to the 1st study visit). Prospectively, refraction, visual acuity, examination findings, intraocular pressure and complications are recorded 1-6 months postoperatively. Depending on the type of IOL, results of further non-invasive measurements are also recorded. Optional follow-up visits with the aforementioned examinations are possible up to 10 years postoperatively.
Study design
- Observational model
- Other
- Time perspective
- Other
- Target follow-up
- 6 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who receive an intraocular lens are offered to participate in the study.
Key inclusion criteria (1 listed)
- Treatment with an intraocular lens implant 18 years of age or older Patient consent Full legal capacity
Key exclusion criteria (1 listed)
- Dementia Pregnancy Breastfeeding
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 ImplantationIntraocular lenses are implanted during cataract surgery to replace the human crystalline lens. | Device | – |
Primary outcome
Functional results with different Intraocular lenses
Time frame: 6 months
Visual acuity with different intraocular lenses is determined.
Contrast sestivitiy with different Intraocular lenses
Time frame: 6 months
Contrast sensitivity with different intraocular lenses is determined.
Anatomical results.
Time frame: 6 months
Anatomical results with different intraocular lenses are determined.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2024.
- Individual participant dataSharing planned: No
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Evaluation of Visual Outcomes, Complications, and Neuroadaptation Following Bilateral Implantation of enVista Envy Trifocal Intraocular Lenses
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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.
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 Intraocular Lens Complication and Intraocular Lens Rotation, run by University Hospital Augsburg at 1 site in Germany.
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 1 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: looking for participants now, as of the sponsor's last update on 5 Mar 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 Germany. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Isabella Baur, MD (0049821 400-2566, Isabella.Baur@uk-augsburg.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional results with different Intraocular lenses (time frame: 6 months). 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 5 Mar 2024.