UveitisNCT00403832
Acrylate Intraocular Lenses in Cataract Surgery of Uveitis Patients
A study testing intraocular lenses: Two foldable, acrylic, sharp edged IOLs: AcrySof™ (AcrySof SA60AT, Alcon), and Akreos adapt™ (Bausch & Lomb) in people with Uveitis and Cataract, run by St. Franziskus Hospital at 1 site in Germany.
Trial summary
Cataract is a common complication in uveitis patients. Cataract operations with intraocular lens implantation are difficult in these patients because of complication due to the biocompatibility of the intraocular lens. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- intraocular lenses: Two foldable, acrylic, sharp edged IOLs: AcrySof™ (AcrySof SA60AT, Alcon), and Akreos adapt™ (Bausch & Lomb)
- Type of treatment
- Medical device
- How many people
- 60 participants
- Where
- 1 siteGermany
- Study dates
- Aug 2005to Feb 2007
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- non infectious uveitis
- no active inflammation
- significant visual disturbance related to lens opacification
Who cannot join
- vitreous opacification
- ocular hypertension/glaucoma
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Ophthalmology at St.-Franziskus Hospital
Münster, 48145
About this study
Official title: Comparison of Two Different Acrylate Intraocular Lenses in Cataract Surgery in Patients With Non-infectious Uveitis
Cataract is a common complication in uveitis patients. Cataract operations with intraocular lens implantation are difficult in these patients because of complication due to the biocompatibility of the intraocular lens. In this study, uveal and capsular biocompatibility of two widely used acrylate intraocular lenses are compared.
- Being tested
- intraocular lenses: Two foldable, acrylic, sharp edged IOLs: AcrySof™ (AcrySof SA60AT, Alcon), and Akreos adapt™ (Bausch & Lomb)
- Medical subject headings
- Uveitis, Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intraocular lenses: Two foldable, acrylic, sharp edged IOLs: AcrySof™ (AcrySof SA60AT, Alcon), and Akreos adapt™ (Bausch & Lomb)Device
What is being measured
The primary outcome is the main question the study is designed to answer.
visual acuity
cell deposits on anterior IOL surface
posterior capsular opacification
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2006 (estimated)
- Study startAug 2005
- Study completionFeb 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for UveitisStudies 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
- None (open label)
- Enrolment
- 60 participants
Sponsor and investigators
- Lead sponsor
- St. Franziskus Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Arnd Heiligenhaus, Md Phd, Principal investigator, Department of Ophthalmology at St.-FranziskusHospital Münster
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00403832
- Sponsor's protocol ID
- 05-2911
- Status last verified
- Aug 2009
- First submitted
- 24 Nov 2006
- Last updated
- 28 Jul 2010
- Results posted
- No
Publications
Roesel M, Heinz C, Koch JM, Heiligenhaus A. Comparison of orbital floor triamcinolone acetonide and oral prednisolone for cataract surgery management in patients with non-infectious uveitis. Graefes Arch Clin Exp Ophthalmol. 2010 May;248(5):715-20. doi: 10.1007/s00417-009-1269-1. Epub 2010 Jan 16.
PubMed 20082200
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Two Different Acrylate Intraocular Lenses in Cataract Surgery in Patients With Non-infectious Uveitis
- ClinicalTrials.gov ID
- NCT00403832
- Acronym / sponsor ID
- 05-2911
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants
- Lead sponsor
- St. Franziskus HospitalUniversity, hospital or other
- Study start
- Aug 2005
- Study completion
- Feb 2007
- First posted
- 27 Nov 2006 (estimated)
- 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.
Cataract is a common complication in uveitis patients. Cataract operations with intraocular lens implantation are difficult in these patients because of complication due to the biocompatibility of the intraocular lens. In this study, uveal and capsular biocompatibility of two widely used acrylate intraocular lenses are compared.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- non infectious uveitis
- no active inflammation
- significant visual disturbance related to lens opacification
Key exclusion criteria (2 listed)
- vitreous opacification
- ocular hypertension/glaucoma
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 lenses: Two foldable, acrylic, sharp edged IOLs: AcrySof™ (AcrySof SA60AT, Alcon), and Akreos adapt™ (Bausch & Lomb) | Device | – |
Primary outcome
visual acuity
cell deposits on anterior IOL surface
posterior capsular opacification
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 28 Jul 2010.
- Derived from this study: PubMed 20082200Roesel M, Heinz C, Koch JM, Heiligenhaus A. Comparison of orbital floor triamcinolone acetonide and oral prednisolone for cataract surgery management in patients with non-infectious uveitis. Graefes Arch Clin Exp Ophthalmol. 2010 May;248(5):715-20. doi: 10.1007/s00417-009-1269-1. Epub 2010 Jan 16.
- Related InfoLink provided by the sponsor.
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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.
Arnd Heiligenhaus, Md Phd principal investigator
Department of Ophthalmology at St.-FranziskusHospital Münster
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 lenses: Two foldable, acrylic, sharp edged IOLs: AcrySof™ (AcrySof SA60AT, Alcon), and Akreos adapt™ (Bausch & Lomb) in people with Uveitis and Cataract, run by St. Franziskus Hospital 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 3 inclusion and 2 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 28 Jul 2010. 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?
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 acuity. 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?
On the ClinicalTrials.gov record for NCT00403832, which also lists 1 linked publication.
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 28 Jul 2010; AzTrials last refreshed its copy on 8 Nov 2026.