Modification of Scleral Suture Fixation of Dislocated IOL

Dislocated Intraocular Lens Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04150263
• Other study ID #: 2018/1838 - 31/2
• Status: Completed
• Phase: N/A
• Start date: November 12, 2018
• Est. completion date: May 12, 2023

Study information

• Verified date: April 2024
• Source: St. Erik Eye Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 117
• Est. completion date: May 12, 2023
• Est. primary completion date: May 12, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Dislocated Intraocular Lens

Intervention

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

Locations

Country	Name	City	State
Sweden	Laura Armonaite	Stockholm

Sponsors (2)

Lead Sponsor	Collaborator
St. Erik Eye Hospital	Umeå University

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Capsular thickness	Measured with OCT and photographed on slit-lamp examination.	preoperatively or as soon as possible postoperatively
Primary	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
Secondary	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
Secondary	Intraocular Pressure (IOP)	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
Secondary	administration of IOL lowering therapy	number of patients who used IOL lowering therapy	through study completion, an average of 1,5 years
Secondary	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
Secondary	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
Secondary	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