Intraocular Lens DislocationLIONNCT03276104
Late In-the-bag intraOcular Lens dislocatioN Surgery
A study testing IOL repositioning and IOL exchange in people with Intraocular Lens Dislocation, run by Oslo University Hospital at 1 site in Norway.
Trial summary
Overall aim of the study is to compare the safety and efficacy of two different surgical methods to treat Late In-the-bag intraocular lens dislocation. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Intraocular Lens Dislocation
- What is being tested?
- IOL repositioning and IOL exchange
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteNorway
- Study dates
- 9 Sep 2017to Dec 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- IOL inside the capsule ("in-the-bag")
- Late dislocation (more than 6 months after cataract surgery)
- IOL visible in the pupillary area in the supine position and hence possible to perform surgery with an anterior approach
- Eligibility for both operation methods
- Ability to cooperate fairly well during the examinations
- Willing to participate in the study, e.g. willingness to participate at all control visits
Who cannot join
- IOL designs that cannot be repositioned with a suture loop, such as plate-haptic IOLs without holes in the peripheral part
- Eyes with especially thin sclera
- Active uveitis or pronounced iris pathology
- Eyes with previously performed Descemet's Stripping Automated Endothelial Keratoplasty (DSAEK)
- Totally dislocated IOL into the posterior segment of the eye requiring pars plana vitrectomy
- Eyes that prior to cataract extraction had a subluxated lens in need of surgery with a Cionni capsular tension ring (e.g. patients with Marfan syndrome and ectopia lentis)
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- Cases requiring a change in refraction. Risk of severe anisometropia
- Patients unable to lie in supine position for surgery in local anesthesia, e.g. severe chronic obstructive pulmonary disease and severe heart failure
- Patients using anticoagulants that cannot be discontinued
- For patients with dislocated IOLs in both eyes during the study period, only the first operated eye will be included. Patients without prospects of improvement in vision will be excluded.
Trial locations and contacts
1 site in 1 country.
Norway1 site, 1 recruiting
- Recruiting
Oslo University Hospital
Oslo
Olav Kristianslund, M.D. M.Phil. PhD cand., +47 41625514, olav.kristianslund@gmail.com
About this study
Official title: Late In-the-bag intraOcular Lens dislocatioN Surgery: A Randomized Clinical Trial (LION Trial)
Overall aim of the study is to compare the safety and efficacy of two different surgical methods to treat Late In-the-bag intraocular lens dislocation.
Read the detailed description
Cataract is a condition of unclear lens that cause poor vision. The only treatment is surgery where the blurred biological lens is replaced with an artificial clear lens (IOL). Most people who operate achieve full vision. Nevertheless, serious complications may occasionally occur, and one of these is dislocation of the entire complex with IOL and lens capsule. This requires surgical treatment.
In this study the investigators want to compare two different surgical methods used in late dislocation of IOL inside the capsule after cataract surgery. Patients will be randomly affiliated to either the suturing of existing IOL / capsule complex, or lens exchange to an IOL fixed to the iris.
The focus of the trial will be especially on complications and other eye changes in the early stages of surgery. Today, little data is available on these topics, and the investigators believe that new knowledge can bring us closer to a response to preferred operating techniques and an optimal drug drop regime for the patient group.
- Conditions
- Intraocular Lens Dislocation
- Being tested
- IOL repositioning, IOL exchange
- Keywords
- IOL dislocation, Cataract, Cataract surgery, Scleral suturing, Verisyse, Iris-claw, Late in-the-bag IOL dislocation
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IOL repositioningProcedure or surgery
Intraocular lens repositioning by scleral suturing
IOL exchangeProcedure or surgery
Intraocular lens exchange with retropupillary iris-claw lens
| Study group | Role | What they receive |
|---|---|---|
| IOL repositioning group | Active comparator | Not described Receives: Procedure: IOL repositioning |
| IOL exchange group | Active comparator | Not described Receives: Procedure: IOL exchange |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inflammation in the anterior chamber after surgery
Measured with a Laser Flare Meter
Measured: The first weeks after surgery
Changes in macular thickness and occurrence of Cystoid macular edema
Evaluated with Optical Coherence Tomography
Measured: The first months after surgery, and long term changes months up to two years after surgery
Intraocular pressure changes
Measured with Goldmann Applanation Tonometry and iCare, both measured in mmhg
Measured: Early changes in the first weeks after surgery, and long term changes months up to two years after surgery
Secondary outcomes (12)
Best Corrected Visual acuity (BCVA)
Measured in LogMar
Measured: Short term (the first weeks and up to 6 months) and long term (up to two years)
Best Corrected Visual acuity (BCVA)
Measured in Snellen
Measured: Short term (the first weeks and up to 6 months) and long term (up to two years)
Glare
Measured by straylight meter
Measured: Medium term (6 months)
Glare
Measured by subjective presence of glare
Measured: Medium term (6 months)
Endothelial cells
Measured by Non-contact corneal confocal microscopy
Measured: Short term (2 weeks) and long term (6months and 2 years)
Intra- and postoperative complications
All relevant complications
Measured: Short term and long term (first post operative day, the first weeks and months, and up to two years)
IOL tilt
Measured with anterior segment Ultra Sound
Measured: 6 months and 2 years
IOL tilt
Measured with Anterior segment optical coherence tomography
Measured: 6 months and 2 years
Refractive outcomes - subjective refraction measured with a phoropter
To compare the refractive outcomes (short and long-term)
Measured: Short term - meaning 2 weeks to 6 months. Long term - meaning up to two years
Refractive outcomes - subjective refraction measured with a phoropter
To determine whether suture placement for IOL repositioning affects the refractive outcome
Measured: Short term - meaning 2 weeks to 6 months. Long term - meaning up to two years
Astigmatism
To compare astigmatism measured by keratometry
Measured: Short term - meaning 2 weeks to 6 months. Long term - meaning up to two years
Astigmatism
To compare astigmatism measured by subjective refraction measured with phoropter
Measured: Short term - meaning 2 weeks to 6 months. Long term - meaning up to two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2017
- Study start9 Sep 2017
- Primary completionNov 2020 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intraocular Lens DislocationStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized clinical trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- South-Eastern Norway Regional Health Authority
- Responsible party
- Principal investigator, Marius Dalby, Oslo University Hospital
- Investigators
- Liv Drolsum, Prof. M.D. PhD, Study chair, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03276104
- Sponsor's protocol ID
- 2017/5506
- Acronym
- LION
- Status last verified
- Apr 2019
- First submitted
- 31 Aug 2017
- Last updated
- 17 Apr 2019
- 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 17 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Late In-the-bag intraOcular Lens dislocatioN Surgery: A Randomized Clinical Trial (LION Trial)
- ClinicalTrials.gov ID
- NCT03276104
- Acronym / sponsor ID
- LION / 2017/5506
- Conditions
- Intraocular Lens Dislocation
- Keywords
- IOL dislocation, Cataract, Cataract surgery, Scleral suturing, Verisyse, Iris-claw, Late in-the-bag IOL dislocation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Collaborators
- South-Eastern Norway Regional Health Authority
- Study start
- 9 Sep 2017 (actual)
- Primary completion
- Nov 2020 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 8 Sep 2017 (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.
Overall aim of the study is to compare the safety and efficacy of two different surgical methods to treat Late In-the-bag intraocular lens dislocation.
Detailed description
Cataract is a condition of unclear lens that cause poor vision. The only treatment is surgery where the blurred biological lens is replaced with an artificial clear lens (IOL). Most people who operate achieve full vision. Nevertheless, serious complications may occasionally occur, and one of these is dislocation of the entire complex with IOL and lens capsule. This requires surgical treatment.
In this study the investigators want to compare two different surgical methods used in late dislocation of IOL inside the capsule after cataract surgery. Patients will be randomly affiliated to either the suturing of existing IOL / capsule complex, or lens exchange to an IOL fixed to the iris.
The focus of the trial will be especially on complications and other eye changes in the early stages of surgery. Today, little data is available on these topics, and the investigators believe that new knowledge can bring us closer to a response to preferred operating techniques and an optimal drug drop regime for the patient group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized clinical trial
| Arm | Type | Receives |
|---|---|---|
| IOL repositioning group | Active comparator | Procedure: IOL repositioning |
| IOL exchange group | Active comparator | Procedure: IOL exchange |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- IOL inside the capsule ("in-the-bag")
- Late dislocation (more than 6 months after cataract surgery)
- IOL visible in the pupillary area in the supine position and hence possible to perform surgery with an anterior approach
- Eligibility for both operation methods
- Ability to cooperate fairly well during the examinations
Key exclusion criteria (10 listed)
- IOL designs that cannot be repositioned with a suture loop, such as plate-haptic IOLs without holes in the peripheral part
- Eyes with especially thin sclera
- Active uveitis or pronounced iris pathology
- Eyes with previously performed Descemet's Stripping Automated Endothelial Keratoplasty (DSAEK)
- Totally dislocated IOL into the posterior segment of the eye requiring pars plana 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 |
|---|---|---|
| IOL repositioningIntraocular lens repositioning by scleral suturing | Procedure or surgery | IOL repositioning group |
| IOL exchangeIntraocular lens exchange with retropupillary iris-claw lens | Procedure or surgery | IOL exchange group |
Primary outcome
Inflammation in the anterior chamber after surgery
Time frame: The first weeks after surgery
Measured with a Laser Flare Meter
Changes in macular thickness and occurrence of Cystoid macular edema
Time frame: The first months after surgery, and long term changes months up to two years after surgery
Evaluated with Optical Coherence Tomography
Intraocular pressure changes
Time frame: Early changes in the first weeks after surgery, and long term changes months up to two years after surgery
Measured with Goldmann Applanation Tonometry and iCare, both measured in mmhg
12 secondary outcomes
Best Corrected Visual acuity (BCVA)
Time frame: Short term (the first weeks and up to 6 months) and long term (up to two years)
Best Corrected Visual acuity (BCVA)
Time frame: Short term (the first weeks and up to 6 months) and long term (up to two years)
Glare
Time frame: Medium term (6 months)
Glare
Time frame: Medium term (6 months)
Endothelial cells
Time frame: Short term (2 weeks) and long term (6months and 2 years)
Intra- and postoperative complications
Time frame: Short term and long term (first post operative day, the first weeks and months, and up to two years)
IOL tilt
Time frame: 6 months and 2 years
IOL tilt
Time frame: 6 months and 2 years
Refractive outcomes - subjective refraction measured with a phoropter
Time frame: Short term - meaning 2 weeks to 6 months. Long term - meaning up to two years
Refractive outcomes - subjective refraction measured with a phoropter
Time frame: Short term - meaning 2 weeks to 6 months. Long term - meaning up to two years
Astigmatism
Time frame: Short term - meaning 2 weeks to 6 months. Long term - meaning up to two years
Astigmatism
Time frame: Short term - meaning 2 weeks to 6 months. Long term - meaning up to two years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2019.
- Individual participant dataSharing planned: No
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.
Liv Drolsum, Prof. M.D. PhD study chair
Oslo University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IOL repositioning and IOL exchange in people with Intraocular Lens Dislocation, run by Oslo University Hospital at 1 site in Norway.
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 6 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: status not confirmed, as of the sponsor's last update on 17 Apr 2019. 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 Norway. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marius Dalby, M.D. PhD Cand. (+47 92408957, marius.dalby@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Inflammation in the anterior chamber after surgery (time frame: The first weeks after surgery). 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 17 Apr 2019.