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
|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|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||104 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Masking Description:||Investigator masked for group affiliation during image analysis|
|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|
Operation method: Intraocular lens repositioning by scleral suturing
Procedure: Intraocular lens repositioning by scleral suturing
Operation method: Intraocular lens exchange with retropupillary iris-claw lens
Procedure: Intraocular lens exchange with retropupillary iris-claw lens
- Best Corrected Visual Acuity (BCVA) [ Time Frame: 6 months, 1 year and 2 years ]Measure for visual function. Measured in logMAR
- Intraocular Pressure (IOP) [ Time Frame: 6 months and 2 years ]Measure for the pressure inside the eye, measured with Goldman applanation tonometer, in mmHg.
- Endothelial Density [ Time Frame: 6 months ]Corneal endothelial cell density (ECD), measured by confocal microscopy. Reported in cells per square millimeter
- Postoperative Complications [ Time Frame: 6 months and 2 years ]Cystoid macular edema considered the most important long-term complication and therefore reported here.
- Keratometry [ Time Frame: 6 months (only analyzed/reported for this time frame) ]Keratometry of the cornea. Corneal astigmatism, measured in diopters.
- 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).
- IOL Location [ Time Frame: 2 years ]Measure IOL's location with slit lamp and Pentacam.
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
|Oslo University Hospital|
|Study Chair:||Liv Drolsum, MD, PhD||Oslo University Hospital|