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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IOL repositioning | Other | Operation method: Intraocular lens repositioning by scleral suturing |
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| IOL exchange | Other | Operation method: Intraocular lens exchange with retropupillary iris-claw lens |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intraocular lens repositioning by scleral suturing | Procedure |
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| Intraocular lens exchange with retropupillary iris-claw lens |
| Measure | Description | Time Frame |
|---|---|---|
| Best Corrected Visual Acuity (BCVA) | Measure for visual function. Measured in logMAR | 6 months, 1 year and 2 years |
| Intraocular Pressure (IOP) | Measure for the pressure inside the eye, measured with Goldman applanation tonometer, in mmHg. | 6 months and 2 years |
| Endothelial Density | Corneal endothelial cell density (ECD), measured by confocal microscopy. Reported in cells per square millimeter | 6 months |
| Postoperative Complications | Cystoid macular edema considered the most important long-term complication and therefore reported here. | 6 months and 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Keratometry | Keratometry of the cornea. Corneal astigmatism, measured in diopters. | 6 months (only analyzed/reported for this time frame) |
| Questionnaire Visual Function-14 (VF-14) Score | Questionnaire considering subjective visual function, scale 0-100 (higher scores mean better subjective visual outcome, lower scores means worse outcome). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Liv Drolsum, MD, PhD | Oslo University Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oslo University Hospital | Oslo | Norway |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33754659 | Derived | Dalby M, Drolsum L, Kristianslund O. Repositioning surgery of different intraocular lens designs in eyes with late in-the-bag intraocular lens dislocation. J Cataract Refract Surg. 2021 Sep 1;47(9):1147-1152. doi: 10.1097/j.jcrs.0000000000000588. | |
| 28973318 | Derived | Kristianslund O, Ostern AE, Drolsum L. Astigmatism and Refractive Outcome After Late In-The-Bag Intraocular Lens Dislocation Surgery: A Randomized Clinical Trial. Invest Ophthalmol Vis Sci. 2017 Sep 1;58(11):4747-4753. doi: 10.1167/iovs.17-22723. |
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Altogether 175 patients were assessed for eligibility, 104 patients were enrolled.
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| ID | Title | Description |
|---|---|---|
| FG000 | IOL Repositioning | Operation method: Intraocular lens repositioning by scleral suturing 54 patients were randomised to this group. 11 patients were lost to follow-up before the 6-month postoperative visit because of serious illness and 1 death (unrelated to the condition studied). |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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Investigator masked for group affiliation during image analysis
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| Procedure |
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| 6 months (only analyzed/reported for this time frame) |
| IOL Location | Measure IOL's location with slit lamp and Pentacam. | 2 years |
| IOL Exchange |
Operation method: Intraocular lens exchange with retropupillary iris-claw lens 50 patients were randomised to this group. 8 patients were lost to follow-up before the 6-month postoperative visit because of serious illness (unrelated to the condition studied). |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | IOL Repositioning | Operation method: Intraocular lens repositioning by scleral suturing |
| BG001 | IOL Exchange | Operation method: Intraocular lens exchange with retropupillary iris-claw lens |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Full Range | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Mean best-corrected visual acuity | Mean | Standard Deviation | logMAR |
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| Mean intraocular pressure | Mean | Standard Deviation | mmHg |
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| Mean time since cataract surgery | Mean | Standard Deviation | years |
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| Mean endothelial cell density | Mean | Standard Deviation | cells/mm^2 |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Best Corrected Visual Acuity (BCVA) | Measure for visual function. Measured in logMAR | Posted | Mean | Standard Deviation | logMAR | 6 months, 1 year and 2 years |
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| Primary | Intraocular Pressure (IOP) | Measure for the pressure inside the eye, measured with Goldman applanation tonometer, in mmHg. | Posted | Mean | Standard Deviation | mmHg | 6 months and 2 years |
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| Primary | Endothelial Density | Corneal endothelial cell density (ECD), measured by confocal microscopy. Reported in cells per square millimeter | Some missing data due to inadequate corneal images | Posted | Mean | Standard Deviation | cells/mm^2 | 6 months |
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| Primary | Postoperative Complications | Cystoid macular edema considered the most important long-term complication and therefore reported here. | Some loss to follow-up | Posted | Count of Participants | Participants | 6 months and 2 years |
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| Secondary | Keratometry | Keratometry of the cornea. Corneal astigmatism, measured in diopters. | Some missing data due to poor image/measurement quality, overall number of participants therefore lower than the number of participants attending the 6-month visit | Posted | Mean | Standard Deviation | Diopters | 6 months (only analyzed/reported for this time frame) |
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| Secondary | Questionnaire Visual Function-14 (VF-14) Score | Questionnaire considering subjective visual function, scale 0-100 (higher scores mean better subjective visual outcome, lower scores means worse outcome). | Some loss to follow-up | Posted | Mean | Standard Deviation | score points | 6 months (only analyzed/reported for this time frame) |
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| Secondary | IOL Location | Measure IOL's location with slit lamp and Pentacam. | Not Posted | Dec 2020 | 2 years | Participants |
6 months
Adverse events were registered as specific perioperative and postoperative complications related to the surgery.
Otherwise we registered the number of participants that were lost to-follow up due to serious illness (other conditions than the studied) or death.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | IOL Repositioning | Operation method: Intraocular lens repositioning by scleral suturing | 1 | 54 | 10 | 54 | 3 | 43 |
| EG001 | IOL Exchange | Operation method: Intraocular lens exchange with retropupillary iris-claw lens | 0 | 50 | 8 | 50 | 4 | 42 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Serious illness | General disorders | Non-systematic Assessment | Serious adverse events were not related to intervention, "General disorders" were therefore chosen as a common term. The study population had a high age and therefore serious illness of some participants were anticipated |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cystoid macular edema | Eye disorders | Non-systematic Assessment | Postoperative complication, registered at the 6-month postoperative visit |
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Limitations to the study / the result:
Some loss to follow-up Some missing data for some of the parameters
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Olav Kristianslund | Oslo University Hospital | +4723015168 | olav.kristianslund@medisin.uio.no |
| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| BCVA 2 years |
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