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| Name | Class |
|---|---|
| Umeå University | OTHER |
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A prospective randomized study on patients with late in the bag intraocular lens (IOL) dislocation after cataract surgery. Two surgical techniques of suturing of IOL to the sclera will be compared in the study. IOL position will be compared between those two groups, as well to a control group consisting of ordinary pseudophakia where only measurement of IOL position will be performed.
In this prospective randomized study 60 patients will be included with late intraocular lens (IOL) dislocation and 60 patients in a control group with ordinary pseudophakia. Traditional surgery includes a capsular-IOL complex fixation to sclera by looping a prolene suture not only around haptics but also through capsular tissue. Such a suture may cut through the bag, which may result in a decentered IOL. A modification of "the traditional" method was created at S:t Eriks Eye Hospital in order to achieve better centration of the IOL. The study will evaluate the efficacy of these two methods. Additionally, the impact of fibrosis of capsular bag on IOL stability postoperatively will be evaluated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Traditional IOL repositioning | Other | Intraocular lens (IOL) ab externo scleral suture fixation |
|
| Modification of traditional IOL repositioning | Other | Modified intraocular lens (IOL) ab externo scleral suture fixation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intraocular lens (IOL) ab externo scleral suture fixation | Procedure | traditional IOL scleral suture fixation |
|
| Measure | Description | Time Frame |
|---|---|---|
| IOL position | Measured at 3 time points: 1 month, 6 months and 1.5 years postoperatively, with anterior optical coherence tomography (OCT). | through study completion, an average of 1,5 years |
| Capsular thickness | Measured with OCT and photographed on slit-lamp examination. | preoperatively or as soon as possible postoperatively |
| Astigmatism | Measured with corneal topography, autorefractometer and keratometer. Corneal and IOL related astigmatism measured in diopters.Measured at 3 time points: 1 month, 6 months and 1.5 years postoperatively, | through study completion, an average of 1,5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Best Corrected Visual Acuity (BCVA) | Measure for visual function. Measured in logMAR. Measured preoperatively, 1 month, 6 months and 1.5 years postoperatively | through study completion, an average of 1,5 years |
| Intraocular Pressure (IOP) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Laura Armonaite | Stockholm | Sweden |
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| ID | Term |
|---|---|
| D004204 | Joint Dislocations |
| ID | Term |
|---|---|
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D014947 | Wounds and Injuries |
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| ID | Term |
|---|---|
| D007910 | Lenses, Intraocular |
| ID | Term |
|---|---|
| D007909 | Lenses |
| D055096 | Optical Devices |
| D004864 | Equipment and Supplies |
| D019736 | Prostheses and Implants |
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1 arm included 56 patients, the other arm included 61 patients. Sixty controls with ordinary pseudophakia.
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| Modified IOL ab externo scleral suture fixation | Procedure | Modified IOL scleral suture fixation |
|
Measure for the pressure inside the eye measured with Goldman applanation tonometer and iCare, both in mmHg. Measured preoperatively, 1 month, 6 months and 1.5 years postoperatively
| through study completion, an average of 1,5 years |
| administration of IOL lowering therapy | number of patients who used IOL lowering therapy | through study completion, an average of 1,5 years |
| Number of participants with postoperative complications | Number of patients with retinal detachment, macular edema and other. | through study completion, an average of 1,5 year |
| Precision of the IOL position measurement with OCT | Measurements of IOL position with OCT will be done 3 times by the same investigator in both mydriatic and non-mydriatic pupil status. | 1 month or any other postoperative control through study completion, an average of 1,5 year |
| inflammation in anterior chamber | Measured at 2 time points: 6 months and 1.5 years postoperatively, with laser flare meter. | through study completion, an average of 1,5 years |