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Late Dislocation of Intraocular Lens (IOL) Following Cataract Surgery: an Evaluation of Two Different Surgical Methods

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ClinicalTrials.gov Identifier: NCT01784926
Recruitment Status : Active, not recruiting
First Posted : February 6, 2013
Results First Posted : September 27, 2019
Last Update Posted : September 27, 2019
Sponsor:
Information provided by (Responsible Party):
Marius Dalby, Oslo University Hospital

Brief Summary:
A prospective randomized study on patients with late in the bag intraocular lens (IOL) dislocation, after cataract surgery. To obtain normal visual function, these patients needs surgery. In this study the investigators will look for advantages and dis-advantages after two different surgical approaches to late in-the-bag IOL dislocation.

Condition or disease Intervention/treatment Phase
Intraocular Lens Dislocation Procedure: Intraocular lens repositioning by scleral suturing Procedure: Intraocular lens exchange with retropupillary iris-claw lens Not Applicable

Detailed Description:
In this prospective, randomized study The investigators will include at least 80 patients with late intraocular lens (IOL) dislocation in the capsular complex, after cataract surgery. To obtain normal visual function, these patients needs surgery. Today, there are two different methods used for this condition; scleral suturing of the capsular complex or exchange of IOL to an iris-fixated IOL (Verisyse). In this study the investigators will look for advantages and dis-advantages for these two methods.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 104 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Masking Description: Investigator masked for group affiliation during image analysis
Primary Purpose: Treatment
Official Title: Late Dislocation of Intraocular Lens (IOL) Following Cataract Surgery: an Evaluation of Two Different Surgical Methods
Study Start Date : January 2013
Actual Primary Completion Date : June 2016
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
IOL repositioning
Operation method: Intraocular lens repositioning by scleral suturing
Procedure: Intraocular lens repositioning by scleral suturing
IOL exchange
Operation method: Intraocular lens exchange with retropupillary iris-claw lens
Procedure: Intraocular lens exchange with retropupillary iris-claw lens



Primary Outcome Measures :
  1. Best Corrected Visual Acuity (BCVA) [ Time Frame: 6 months, 1 year and 2 years ]
    Measure for visual function. Measured in logMAR

  2. Intraocular Pressure (IOP) [ Time Frame: 6 months and 2 years ]
    Measure for the pressure inside the eye, measured with Goldman applanation tonometer, in mmHg.

  3. Endothelial Density [ Time Frame: 6 months ]
    Corneal endothelial cell density (ECD), measured by confocal microscopy. Reported in cells per square millimeter

  4. Postoperative Complications [ Time Frame: 6 months and 2 years ]
    Cystoid macular edema considered the most important long-term complication and therefore reported here.


Secondary Outcome Measures :
  1. Keratometry [ Time Frame: 6 months (only analyzed/reported for this time frame) ]
    Keratometry of the cornea. Corneal astigmatism, measured in diopters.

  2. Questionnaire Visual Function-14 (VF-14) Score [ Time Frame: 6 months (only analyzed/reported for this time frame) ]
    Questionnaire considering subjective visual function, scale 0-100 (higher scores mean better subjective visual outcome, lower scores means worse outcome).

  3. IOL Location [ Time Frame: 2 years ]
    Measure IOL's location with slit lamp and Pentacam.



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

Inclusion Criteria:

  • patients with dislocation of IOL in the capsular complex who agree to participate in the study

Exclusion Criteria:

  • patients with total dislocation of the capsular complex'
  • patients with reduced general health
  • patients who can't be randomized

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): NCT01784926


Locations
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Norway
Oslo University Hospital
Oslo, Norway
Sponsors and Collaborators
Oslo University Hospital
Investigators
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Study Chair: Liv Drolsum, MD, PhD Oslo University Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Marius Dalby, MSc, Oslo University Hospital
ClinicalTrials.gov Identifier: NCT01784926     History of Changes
Other Study ID Numbers: 2012/1981
First Posted: February 6, 2013    Key Record Dates
Results First Posted: September 27, 2019
Last Update Posted: September 27, 2019
Last Verified: September 2019
Keywords provided by Marius Dalby, Oslo University Hospital:
cataract surgery
scleral suturing
Verisyse
Late in-the-bag IOL dislocation
Additional relevant MeSH terms:
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Joint Dislocations
Cataract
Lens Subluxation
Lens Diseases
Eye Diseases
Joint Diseases
Musculoskeletal Diseases
Wounds and Injuries