LEC Proliferation in Vivo and In-vitro

• Conditions: Posterior Capsule Opacification
• Interventions: Procedure: In-vitro model

• Registration Number: NCT03857685
• Lead Sponsor: Prim. Prof. Dr. Oliver Findl, MBA

Brief Summary

Investigate the proliferative capacity of individual lens epithelium capsule specimens in vitro and correlate it to the risk of developing PCO

Detailed Description

Cataract, the clouding of the eye's lens, is still the leading cause of blindness worldwide. Until now surgery is the only therapy available for the disease. Cataract surgery is nowadays considered a safe and efficient therapy. However, one of the most frequent complications of cataract surgery is posterior capsule opacification (PCO), which results in diminished postoperative visual acuity. PCO occurs due to a robust wound-healing response, where remaining lens epithelial cells in the capsular bag start to migrate and proliferate.

The lens capsule is divided into an anterior, an equatorial, and a posterior region. The anterior and the equatorial region consist of a single layer of cuboidal epithelial cells, whilst the posterior region is formed of fibers. In the adult lens proliferation occurs almost exclusively in the equatorial region and although the central part of the lens epithelium exhibits very low mitotic activity, it was shown in experiments that cell in this area are also stem cells. There are three possible reasons for the generation of PCO: intraoperative factors (dependening on the amount of remaining cells in the capsular bag), intraocular lens factors, and interpersonal factor (patient-specific factors).

Aim of this study is the generation of an in-vitro model of posterior capsule opacification. Therefore, the investigators will analyse the proliferative capacity of lens epithelial cells on the lens capsule, which is removed during cataract surgery, in a cell culture model. The investigators then compare the proliferative capacity between young and old patients, between both eyes of the same patient, and in different forms of cataract.

Study Timeline

• Study Start: 2019-01-01
• Study First Submitted: 2019-02-26
• Study First Submitted QC: 2019-02-26
• Study First Posted: 2019-02-28
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-13
• Last Update Posted: 2020-03-16
• Primary Completion: 2020-05-01
• Study Completion: 2021-01-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Age-related cataract.
• Patients in the age group of 21 years and older.
• Patients with uncomplicated cataract.
• Patients without any relevant systemic or ocular morbidity.
• Patients with well dilating pupils.
• Written informed consent prior to any study specific action.

Exclusion Criteria

• Patients with complicated cataract.
• Patients with big differences in LOCS scale between the two eyes.
• Patients having corneal pathology.
• Patients with any form of ocular inflammation.
• Patients with glaucoma, retinal pathologies.
• Patients with traumatic cataracts, subluxated and dislocated lens, prior h/o ocular surgery, pseudoexfoliation.
• Any intraoperative complications like posterior capsule rupture.
• In case of pregnancy (pregnancy test will be taken preoperatively in women of reproductive age).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Proliferation in an in-vitro model	In-vitro model	An in-vitro model is used to study lens epithelial cell proliferation

Primary Outcome Measures

Name	Time	Method
Amount of proliferation of lens epithelial cells (LECs) in-vitro compared to in vivo in the same patient	24 months	Proliferation of LECs in-vitro will be measured as area/mm2 and correlated with ratings of posterior capsular opacification in vivo using a scale from 0 to 10

Secondary Outcome Measures

Name	Time	Method
Amount of proliferation of LECs in-vitro in young and older patients	24 months	Proliferation of LECs in-vitro will be measured as area/mm2 and compared between older and younger individuals
Amount of proliferation of LECs in-vitro between different forms of cataract	24 months	Proliferation of LECs in-vitro will be measured as area/mm2 and compared between the different forms of cataract (cortical, nuclear, posterior subcapsular)

Trial Locations

Locations (1)

Vienna Institute for Research in Ocular Surgery (VIROS); 🇦🇹 Vienna, Austria