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Late In-the-bag intraOcular Lens dislocatioN Surgery (LION)

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ClinicalTrials.gov Identifier: NCT03276104
Recruitment Status : Recruiting
First Posted : September 8, 2017
Last Update Posted : September 13, 2017
Sponsor:
Collaborator:
South-Eastern Norway Regional Health Authority
Information provided by (Responsible Party):
Marius Dalby, Oslo University Hospital

Brief 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.

Condition or disease Intervention/treatment Phase
Intraocular Lens Dislocation Procedure: IOL repositioning Procedure: IOL exchange Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized clinical trial
Masking: Single (Outcomes Assessor)
Masking Description: Masking of research optometrists to group affiliation at the postoperative examinations will be endeavored. A physician will perform slit lamp examinations at the postoperative visits, hence he/she cannot be masked, nor can the surgeon. The investigator will be masked during the image analysis.
Primary Purpose: Treatment
Official Title: Late In-the-bag intraOcular Lens dislocatioN Surgery: A Randomized Clinical Trial (LION Trial)
Actual Study Start Date : September 9, 2017
Estimated Primary Completion Date : November 2020
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dislocations

Arm Intervention/treatment
Active Comparator: IOL repositioning group Procedure: IOL repositioning
Intraocular lens repositioning by scleral suturing

Active Comparator: IOL exchange group Procedure: IOL exchange
Intraocular lens exchange with retropupillary iris-claw lens




Primary Outcome Measures :
  1. Inflammation in the anterior chamber after surgery [ Time Frame: The first weeks after surgery ]
    Measured with a Laser Flare Meter

  2. 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

  3. 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


Secondary Outcome Measures :
  1. Best Corrected Visual acuity (BCVA) [ Time Frame: Short term (the first weeks and up to 6 months) and long term (up to two years) ]
    Measured in LogMar

  2. Best Corrected Visual acuity (BCVA) [ Time Frame: Short term (the first weeks and up to 6 months) and long term (up to two years) ]
    Measured in Snellen

  3. Glare [ Time Frame: Medium term (6 months) ]
    Measured by straylight meter

  4. Glare [ Time Frame: Medium term (6 months) ]
    Measured by subjective presence of glare

  5. Endothelial cells [ Time Frame: Short term (2 weeks) and long term (6months and 2 years) ]
    Measured by Non-contact corneal confocal microscopy

  6. 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) ]
    All relevant complications

  7. IOL tilt [ Time Frame: 6 months and 2 years ]
    Measured with anterior segment Ultra Sound

  8. IOL tilt [ Time Frame: 6 months and 2 years ]
    Measured with Anterior segment optical coherence tomography

  9. 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 ]
    To compare the refractive outcomes (short and long-term)

  10. 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 ]
    To determine whether suture placement for IOL repositioning affects the refractive outcome

  11. Astigmatism [ Time Frame: Short term - meaning 2 weeks to 6 months. Long term - meaning up to two years ]
    To compare astigmatism measured by keratometry

  12. Astigmatism [ Time Frame: Short term - meaning 2 weeks to 6 months. Long term - meaning up to two years ]
    To compare astigmatism measured by subjective refraction measured with phoropter



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)
  • 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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03276104


Contacts
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Contact: Marius Dalby, M.D. PhD Cand. +47 92408957 marius.dalby@gmail.com

Locations
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Norway
Oslo University Hospital Recruiting
Oslo, Norway
Contact: Olav Kristianslund, M.D. M.Phil. PhD cand.    +47 41625514    olav.kristianslund@gmail.com   
Sponsors and Collaborators
Oslo University Hospital
South-Eastern Norway Regional Health Authority
Investigators
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Study Chair: Liv Drolsum, Prof. M.D. PhD Oslo University Hospital

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Responsible Party: Marius Dalby, Principal Investigator, M.D., PhD Candidate, Oslo University Hospital
ClinicalTrials.gov Identifier: NCT03276104     History of Changes
Other Study ID Numbers: 2017/5506
First Posted: September 8, 2017    Key Record Dates
Last Update Posted: September 13, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Marius Dalby, Oslo University Hospital:
IOL dislocation
Cataract
Cataract surgery
Scleral suturing
Verisyse
Iris-claw
Late in-the-bag IOL dislocation

Additional relevant MeSH terms:
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Joint Dislocations
Lens Subluxation
Joint Diseases
Musculoskeletal Diseases
Wounds and Injuries
Lens Diseases
Eye Diseases