Clinical trial NCT04150263: Modification of Scleral Suture Fixation of Dislocated IOL
Official title: Dislocated Intraocular Lenses: Effect of Modification of Surgical Repositioning and Capsular Fibrosis Impact on Position of IOL After Fixation Surgery in a Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dislocated Intraocular Lens
Keywords: intraocular lens, dislocation
Lead sponsor: St. Erik Eye Hospital
Sponsor class: OTHER
Collaborators: name: Umeå University
First posted: 2019-11-04
Enrollment: 117
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 1 arm included 56 patients, the other arm included 61 patients. Sixty controls with ordinary pseudophakia.
Primary purpose: TREATMENT

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.

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.

Eligibility 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.

Primary outcomes:
measure: IOL position
timeFrame: through study completion, an average of 1,5 years
measure: Capsular thickness
timeFrame: preoperatively or as soon as possible postoperatively
measure: Astigmatism
timeFrame: through study completion, an average of 1,5 years
Secondary outcomes:
measure: Best Corrected Visual Acuity (BCVA)
timeFrame: through study completion, an average of 1,5 years
measure: Intraocular Pressure (IOP)
timeFrame: through study completion, an average of 1,5 years
measure: administration of IOL lowering therapy
timeFrame: through study completion, an average of 1,5 years
measure: Number of participants with postoperative complications
timeFrame: through study completion, an average of 1,5 year
measure: Precision of the IOL position measurement with OCT
timeFrame: 1 month or any other postoperative control through study completion, an average of 1,5 year
measure: inflammation in anterior chamber
timeFrame: through study completion, an average of 1,5 years
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Laura Armonaite
Study officials:
References: