Late In-the-bag intraOcular Lens dislocatioN Surgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-09-09

Study Completion Date

2022-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Overall aim of the study is to compare the safety and efficacy of two different surgical methods to treat Late In-the-bag intraocular lens dislocation.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Comparison of Methods for Assessing Intraocular Lens Position

NCT07218419

Tilt and Decentration

RECRUITING

Evaluation of 3 Intraocular Lenses Following Lens Extraction

NCT01122576

Cataract

COMPLETED PHASE4

Objective Assessment of Intraocular Lens Tilt and Decentration

NCT07324200

Tilt and Decentration

NOT_YET_RECRUITING

Subjective and Objective Refraction in Pseudophakic Patients

NCT04319497

Pseudophakia

COMPLETED NA

Comparing Visual Outcomes in Matched Patients Receiving a Low Cylinder Power Toric IOL or a Non-toric IOL

NCT06717607

Cataract and IOL Surgery

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Cataract is a condition of unclear lens that cause poor vision. The only treatment is surgery where the blurred biological lens is replaced with an artificial clear lens (IOL). Most people who operate achieve full vision. Nevertheless, serious complications may occasionally occur, and one of these is dislocation of the entire complex with IOL and lens capsule. This requires surgical treatment.

In this study the investigators want to compare two different surgical methods used in late dislocation of IOL inside the capsule after cataract surgery. Patients will be randomly affiliated to either the suturing of existing IOL / capsule complex, or lens exchange to an IOL fixed to the iris.

The focus of the trial will be especially on complications and other eye changes in the early stages of surgery. Today, little data is available on these topics, and the investigators believe that new knowledge can bring us closer to a response to preferred operating techniques and an optimal drug drop regime for the patient group.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Intraocular Lens Dislocation

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized clinical trial

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Masking of research optometrists to group affiliation at the postoperative examinations will be endeavored. A physician will perform slit lamp examinations at the postoperative visits, hence he/she cannot be masked, nor can the surgeon. The investigator will be masked during the image analysis.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

IOL repositioning group

Group Type ACTIVE_COMPARATOR

IOL repositioning

Intervention Type PROCEDURE

Intraocular lens repositioning by scleral suturing

IOL exchange group

Group Type ACTIVE_COMPARATOR

IOL exchange

Intervention Type PROCEDURE

Intraocular lens exchange with retropupillary iris-claw lens

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

IOL repositioning

Intraocular lens repositioning by scleral suturing

Intervention Type PROCEDURE

IOL exchange

Intraocular lens exchange with retropupillary iris-claw lens

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* IOL inside the capsule ("in-the-bag")
* Late dislocation (more than 6 months after cataract surgery)
* IOL visible in the pupillary area in the supine position and hence possible to perform surgery with an anterior approach
* Eligibility for both operation methods
* Ability to cooperate fairly well during the examinations
* Willing to participate in the study, e.g. willingness to participate at all control visits

Exclusion Criteria

* IOL designs that cannot be repositioned with a suture loop, such as plate-haptic IOLs without holes in the peripheral part
* Eyes with especially thin sclera
* Active uveitis or pronounced iris pathology
* Eyes with previously performed Descemet's Stripping Automated Endothelial Keratoplasty (DSAEK)
* Totally dislocated IOL into the posterior segment of the eye requiring pars plana vitrectomy
* Eyes that prior to cataract extraction had a subluxated lens in need of surgery with a Cionni capsular tension ring (e.g. patients with Marfan syndrome and ectopia lentis)
* Cases requiring a change in refraction. Risk of severe anisometropia
* Patients unable to lie in supine position for surgery in local anesthesia, e.g. severe chronic obstructive pulmonary disease and severe heart failure
* Patients using anticoagulants that cannot be discontinued

For patients with dislocated IOLs in both eyes during the study period, only the first operated eye will be included. Patients without prospects of improvement in vision will be excluded.

Eligible Sex

ALL

Accepts Healthy Volunteers

No