Intraocular Lens Dislocation
Conditions
Keywords
cataract surgery, scleral suturing, Verisyse, Late in-the-bag IOL dislocation
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.
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.
Interventions
PROCEDUREIntraocular lens repositioning by scleral suturing
PROCEDUREIntraocular lens exchange with retropupillary iris-claw lens
Sponsors
Oslo University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
Investigator masked for group affiliation during image analysis
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative Complications | 6 months and 2 years | Cystoid macular edema considered the most important long-term complication and therefore reported here. |
| Best Corrected Visual Acuity (BCVA) | 6 months, 1 year and 2 years | Measure for visual function. Measured in logMAR |
| Intraocular Pressure (IOP) | 6 months and 2 years | Measure for the pressure inside the eye, measured with Goldman applanation tonometer, in mmHg. |
| Endothelial Density | 6 months | Corneal endothelial cell density (ECD), measured by confocal microscopy. Reported in cells per square millimeter |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Questionnaire Visual Function-14 (VF-14) Score | 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 | 2 years | Measure IOL's location with slit lamp and Pentacam. |
| Keratometry | 6 months (only analyzed/reported for this time frame) | Keratometry of the cornea. Corneal astigmatism, measured in diopters. |
Countries
Norway
Participant flow
Recruitment details
Altogether 175 patients were assessed for eligibility, 104 patients were enrolled.
Participants by arm
| Arm | Count |
|---|---|
| IOL Repositioning Operation method: Intraocular lens repositioning by scleral suturing | 54 |
| IOL Exchange Operation method: Intraocular lens exchange with retropupillary iris-claw lens | 50 |
| Total | 104 |
Baseline characteristics
| Characteristic | IOL Repositioning | IOL Exchange | Total |
|---|---|---|---|
| Age, Continuous | 81 years | 82 years | 81.5 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 54 Participants | 50 Participants | 104 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Mean best-corrected visual acuity | 0.37 logMAR STANDARD_DEVIATION 0.42 | 0.64 logMAR STANDARD_DEVIATION 0.77 | 0.50 logMAR STANDARD_DEVIATION 0.63 |
| Mean endothelial cell density | 1940 cells/mm^2 STANDARD_DEVIATION 418 | 1718 cells/mm^2 STANDARD_DEVIATION 449 | 1839 cells/mm^2 STANDARD_DEVIATION 444 |
| Mean intraocular pressure | 17.7 mmHg STANDARD_DEVIATION 5 | 18.3 mmHg STANDARD_DEVIATION 7.2 | 18.0 mmHg STANDARD_DEVIATION 6.2 |
| Mean time since cataract surgery | 10.6 years STANDARD_DEVIATION 4.3 | 10.0 years STANDARD_DEVIATION 4.3 | 10.3 years STANDARD_DEVIATION 4.3 |
| Region of Enrollment Norway | 54 Participants | 50 Participants | 104 Participants |
| Sex: Female, Male Female | 34 Participants | 29 Participants | 63 Participants |
| Sex: Female, Male Male | 20 Participants | 21 Participants | 41 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 54 | 0 / 50 |
| other Total, other adverse events | 3 / 43 | 4 / 42 |
| serious Total, serious adverse events | 10 / 54 | 8 / 50 |
Outcome results
Primary
Best Corrected Visual Acuity (BCVA)
Measure for visual function. Measured in logMAR
Time frame: 6 months, 1 year and 2 years
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| IOL Repositioning | Best Corrected Visual Acuity (BCVA) | BCVA 6 months | 0.24 logMAR | Standard Deviation 0.29 |
| IOL Repositioning | Best Corrected Visual Acuity (BCVA) | BCVA 1 year | 0.21 logMAR | Standard Deviation 0.26 |
| IOL Repositioning | Best Corrected Visual Acuity (BCVA) | BCVA 2 years | 0.20 logMAR | Standard Deviation 0.29 |
| IOL Exchange | Best Corrected Visual Acuity (BCVA) | BCVA 6 months | 0.35 logMAR | Standard Deviation 0.54 |
| IOL Exchange | Best Corrected Visual Acuity (BCVA) | BCVA 1 year | 0.23 logMAR | Standard Deviation 0.34 |
| IOL Exchange | Best Corrected Visual Acuity (BCVA) | BCVA 2 years | 0.22 logMAR | Standard Deviation 0.3 |
Primary
Endothelial Density
Corneal endothelial cell density (ECD), measured by confocal microscopy. Reported in cells per square millimeter
Time frame: 6 months
Population: Some missing data due to inadequate corneal images
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IOL Repositioning | Endothelial Density | 1858 cells/mm^2 | Standard Deviation 433 |
| IOL Exchange | Endothelial Density | 1514 cells/mm^2 | Standard Deviation 470 |
Primary
Intraocular Pressure (IOP)
Measure for the pressure inside the eye, measured with Goldman applanation tonometer, in mmHg.
Time frame: 6 months and 2 years
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| IOL Repositioning | Intraocular Pressure (IOP) | IOP 6 months | 16.5 mmHg | Standard Deviation 5.2 |
| IOL Repositioning | Intraocular Pressure (IOP) | IOP 2 years | 15.7 mmHg | Standard Deviation 4 |
| IOL Exchange | Intraocular Pressure (IOP) | IOP 6 months | 14.9 mmHg | Standard Deviation 4.2 |
| IOL Exchange | Intraocular Pressure (IOP) | IOP 2 years | 14.1 mmHg | Standard Deviation 4.2 |
Primary
Postoperative Complications
Cystoid macular edema considered the most important long-term complication and therefore reported here.
Time frame: 6 months and 2 years
Population: Some loss to follow-up
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| IOL Repositioning | Postoperative Complications | CME 6 months | Cystoid macular edema | 3 Participants |
| IOL Repositioning | Postoperative Complications | CME 6 months | No cystoid macular edema | 40 Participants |
| IOL Repositioning | Postoperative Complications | CME 2 years | Cystoid macular edema | 5 Participants |
| IOL Repositioning | Postoperative Complications | CME 2 years | No cystoid macular edema | 38 Participants |
| IOL Exchange | Postoperative Complications | CME 2 years | No cystoid macular edema | 36 Participants |
| IOL Exchange | Postoperative Complications | CME 6 months | Cystoid macular edema | 4 Participants |
| IOL Exchange | Postoperative Complications | CME 2 years | Cystoid macular edema | 6 Participants |
| IOL Exchange | Postoperative Complications | CME 6 months | No cystoid macular edema | 38 Participants |
Secondary
IOL Location
Measure IOL's location with slit lamp and Pentacam.
Time frame: 2 years
Secondary
Keratometry
Keratometry of the cornea. Corneal astigmatism, measured in diopters.
Time frame: 6 months (only analyzed/reported for this time frame)
Population: 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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IOL Repositioning | Keratometry | 1.2 Diopters | Standard Deviation 1 |
| IOL Exchange | Keratometry | 1.2 Diopters | Standard Deviation 0.8 |
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).
Time frame: 6 months (only analyzed/reported for this time frame)
Population: Some loss to follow-up
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IOL Repositioning | Questionnaire Visual Function-14 (VF-14) Score | 91.6 score points | Standard Deviation 16.4 |
| IOL Exchange | Questionnaire Visual Function-14 (VF-14) Score | 90.1 score points | Standard Deviation 18.2 |