Modification of Scleral Suture Fixation of Dislocated IOL

St. Erik Eye Hospital

Status: Completed

Conditions: Dislocated Intraocular Lens

Treatments: Procedure: Modified IOL ab externo scleral suture fixation; Procedure: Intraocular lens (IOL) ab externo scleral suture fixation

Study type: Interventional

Funder types: Other

Identifiers

NCT04150263

2018/1838 - 31/2

Details and patient eligibility

About

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.

Full 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.

Enrollment: 117 patients

Sex: All

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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117 participants in 2 patient groups

Traditional IOL repositioning

Other group

Description:

Intraocular lens (IOL) ab externo scleral suture fixation

Treatment:

Procedure: Intraocular lens (IOL) ab externo scleral suture fixation

Modification of traditional IOL repositioning

Other group

Description:

Modified intraocular lens (IOL) ab externo scleral suture fixation

Treatment:

Procedure: Modified IOL ab externo scleral suture fixation