Modification of Scleral Suture Fixation of Dislocated IOL
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Other: Traditional IOL repositioning Intraocular lens (IOL) ab externo scleral suture fixation |
Procedure: Intraocular lens (IOL) ab externo scleral suture fixation
traditional IOL scleral suture fixation
|
| Other: Modification of traditional IOL repositioning Modified intraocular lens (IOL) ab externo scleral suture fixation |
Procedure: Modified IOL ab externo scleral suture fixation
Modified IOL scleral suture fixation
|
Outcome Measures
Primary Outcome Measures
- IOL position [through study completion, an average of 1,5 years]
Measured at 3 time points: 1 month, 6 months and 1.5 years postoperatively, with anterior optical coherence tomography (OCT).
- Capsular thickness [preoperatively or as soon as possible postoperatively]
Measured with OCT and photographed on slit-lamp examination.
- Astigmatism [through study completion, an average of 1,5 years]
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,
Secondary Outcome Measures
- Best Corrected Visual Acuity (BCVA) [through study completion, an average of 1,5 years]
Measure for visual function. Measured in logMAR. Measured preoperatively, 1 month, 6 months and 1.5 years postoperatively
- Intraocular Pressure (IOP) [through study completion, an average of 1,5 years]
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
- administration of IOL lowering therapy [through study completion, an average of 1,5 years]
number of patients who used IOL lowering therapy
- Number of participants with postoperative complications [through study completion, an average of 1,5 year]
Number of patients with retinal detachment, macular edema and other.
- Precision of the IOL position measurement with OCT [1 month or any other postoperative control through study completion, an average of 1,5 year]
Measurements of IOL position with OCT will be done 3 times by the same investigator in both mydriatic and non-mydriatic pupil status.
- inflammation in anterior chamber [through study completion, an average of 1,5 years]
Measured at 2 time points: 6 months and 1.5 years postoperatively, with laser flare meter.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
patients with in-the-bag dislocated IOL who agree to participate in the study
-
Inclusion criteria for the control group: pseudophakic eyes 7-10 years after uneventful cataract surgery.
Exclusion Criteria:
-
patients with dislocated IOL that is not visible in the pupillary plane
-
IOL design not suitable for suturing using capsular bag
-
patients who are not able to cooperate under measurements
-
patients with Marfan syndrome and ectopia lentis
-
exclusion criterion for the control group: other eye surgery.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Laura Armonaite | Stockholm | Sweden |
Sponsors and Collaborators
- St. Erik Eye Hospital
- Umeå University
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2018/1838 - 31/2