UveitisNCT02975895
Outcome of Different IOLs in Patients With and Without Uveitis
A study testing Hydrophobic IOL: Vivinex (HOYA) and Hydrophilic IOL: INCISE (Bausch+Lomb) in people with Uveitis and Cataract, run by Vastra Gotaland Region at 1 site in Sweden.
Trial summary
Cataract, is a clouding of the lens in the eye gradually leading to reduction of the visual acuity. In most cases it can be managed with surgery, removing the own lens and replacing it with an artificial lens, intraocular lens (IOL). These lenses are made in different materials with different properties. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Uveitis, Cataract, Inflammation
- What is being tested?
- Hydrophobic IOL: Vivinex (HOYA) and Hydrophilic IOL: INCISE (Bausch+Lomb)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteSweden
- Study dates
- 30 Dec 2016to 17 Mar 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Cataract requiring surgery
- Ability to understand and sign consent form
Who cannot join
- Extensive corneal scarring
- Other eye surgery less than 3 months before inclusion
- Unregulated glaucoma
- Active uveitis (increased inflammation and treatment less than 3 months before inclusion)
- Intraoperative complications (capsular tear or vitreous loss)
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Vastra Gotaland Region, Sahlgrenska University Hospital, Department of Ophthalmology
Mölndal
About this study
Official title: Outcome With Hydrophobic and Hydrophilic Intraocular Lens in Patients With and Without Uveitis
Cataract, is a clouding of the lens in the eye gradually leading to reduction of the visual acuity. In most cases it can be managed with surgery, removing the own lens and replacing it with an artificial lens, intraocular lens (IOL). These lenses are made in different materials with different properties.
Uveitis refers to an inflammation in the iris, ciliary body and choroid. Patients with this disease have an increased risk of developing cataract due to the inflammation itself and treatment with steroids. They also have an increased risk of complications during surgery and postoperatively. In this group the selection of IOL might be of greater importance.
The aim of this prospective randomized controlled study is to compare the outcome of hydrophobic and hydrophilic intraocular lenses in patients with and without uveitis
- Conditions
- Uveitis, Cataract, Inflammation, Posterior Capsule Opacification
- Being tested
- Hydrophobic IOL: Vivinex (HOYA), Hydrophilic IOL: INCISE (Bausch+Lomb)
- Medical subject headings
- Uveitis, Cataract, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hydrophobic IOL: Vivinex (HOYA)Device
Patients requiring cataract surgery will be randomized to one of the two types of IOLs.
Hydrophilic IOL: INCISE (Bausch+Lomb)Device
Patients requiring cataract surgery will be randomized to one of the two types of IOLs.
| Study group | Role | What they receive |
|---|---|---|
| Hydrophobic IOL: Vivinex (HOYA) | Other | Intraocular lens with hydrophobic properties: Vivinex (HOYA). Receives: Device: Hydrophobic IOL: Vivinex (HOYA) |
| Hydrophilic IOL: INCISE (Bausch+Lomb) | Other | Intraocular lens with hydrophilic properties: INCISE (Bausch+Lomb). Receives: Device: Hydrophilic IOL: INCISE (Bausch+Lomb) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in inflammatory response
Measured: Preoperatively and at seven occasions within two years postoperatively
Secondary outcomes (5)
Evaluation of posterior capsule opacification after six months
Measured: Six months (plus or minus 30 days) postoperatively
Evaluation of posterior capsule opacification after one year
Measured: One year (plus or minus 30 days) postoperatively
Evaluation of posterior capsule opacification after two years
Measured: Two years (plus or minus 2 months) postoperatively
Change in best corrected visual acuity assessed in decimal using Snellen charts
Measured: Preoperatively and at six occasions within two years postoperatively
Complications
Postoperative glaucoma or cystoid macular edema
Measured: Preoperatively and at seven occasions within two years postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2016 (estimated)
- Study start30 Dec 2016
- Primary completion22 Feb 2021
- Study completion17 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vastra Gotaland Region
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Madeleine Zetterberg, MD, PhD, Principal investigator, Västra Götalands regionen, Sahlgrenska University Hospital, Department of Ophthalmology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02975895
- Sponsor's protocol ID
- 031-16
- Status last verified
- Aug 2023
- First submitted
- 15 Nov 2016
- Last updated
- 30 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcome With Hydrophobic and Hydrophilic Intraocular Lens in Patients With and Without Uveitis
- ClinicalTrials.gov ID
- NCT02975895
- Acronym / sponsor ID
- 031-16
- Conditions
- Uveitis, Cataract, Inflammation, Posterior Capsule Opacification
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Vastra Gotaland RegionOther government
- Study start
- 30 Dec 2016 (actual)
- Primary completion
- 22 Feb 2021 (actual)
- Study completion
- 17 Mar 2022 (actual)
- First posted
- 29 Nov 2016 (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 clouding of the lens in the eye gradually leading to reduction of the visual acuity. In most cases it can be managed with surgery, removing the own lens and replacing it with an artificial lens, intraocular lens (IOL). These lenses are made in different materials with different properties.
Uveitis refers to an inflammation in the iris, ciliary body and choroid. Patients with this disease have an increased risk of developing cataract due to the inflammation itself and treatment with steroids. They also have an increased risk of complications during surgery and postoperatively. In this group the selection of IOL might be of greater importance.
The aim of this prospective randomized controlled study is to compare the outcome of hydrophobic and hydrophilic intraocular lenses in patients with and without uveitis
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hydrophobic IOL: Vivinex (HOYA) | Other | Device: Hydrophobic IOL: Vivinex (HOYA)Intraocular lens with hydrophobic properties: Vivinex (HOYA). |
| Hydrophilic IOL: INCISE (Bausch+Lomb) | Other | Device: Hydrophilic IOL: INCISE (Bausch+Lomb)Intraocular lens with hydrophilic properties: INCISE (Bausch+Lomb). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Cataract requiring surgery
- Ability to understand and sign consent form
Key exclusion criteria (5 listed)
- Extensive corneal scarring
- Other eye surgery less than 3 months before inclusion
- Unregulated glaucoma
- Active uveitis (increased inflammation and treatment less than 3 months before inclusion)
- Intraoperative complications (capsular tear or vitreous loss)
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 |
|---|---|---|
| Hydrophobic IOL: Vivinex (HOYA)Patients requiring cataract surgery will be randomized to one of the two types of IOLs. | Device | Hydrophobic IOL: Vivinex (HOYA) |
| Hydrophilic IOL: INCISE (Bausch+Lomb)Patients requiring cataract surgery will be randomized to one of the two types of IOLs. | Device | Hydrophilic IOL: INCISE (Bausch+Lomb) |
Primary outcome
Change in inflammatory response
Time frame: Preoperatively and at seven occasions within two years postoperatively
5 secondary outcomes
Evaluation of posterior capsule opacification after six months
Time frame: Six months (plus or minus 30 days) postoperatively
Evaluation of posterior capsule opacification after one year
Time frame: One year (plus or minus 30 days) postoperatively
Evaluation of posterior capsule opacification after two years
Time frame: Two years (plus or minus 2 months) postoperatively
Change in best corrected visual acuity assessed in decimal using Snellen charts
Time frame: Preoperatively and at six occasions within two years postoperatively
Complications
Time frame: Preoperatively and at seven occasions within two years 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 Aug 2023.
- Individual participant dataSharing planned: Undecided
Related trials for Uveitis
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A Phase 3 Study of VVN461 Ophthalmic Solution for Noninfectious Anterior Uveitis
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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.
Madeleine Zetterberg, MD, PhD principal investigator
Västra Götalands regionen, Sahlgrenska University Hospital, Department of Ophthalmology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hydrophobic IOL: Vivinex (HOYA) and Hydrophilic IOL: INCISE (Bausch+Lomb) in people with Uveitis and Cataract, run by Vastra Gotaland Region at 1 site in Sweden.
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 5 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 Aug 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 Sweden. 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?
Change in inflammatory response (time frame: Preoperatively and at seven occasions within two years postoperatively). 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 Aug 2023; AzTrials last refreshed its copy on 26 Oct 2026.