LEC Proliferation in Vivo and In-vitro

Bilateral and Age-dependent Differences in Posterior Capsule Opacification in Vivo Compared to an In-vitro Mode

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

Study Overview

• Status: Unknown
• Conditions: Posterior Capsule Opacification
• Intervention / Treatment: Procedure: In-vitro model

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 Type: Observational
• Enrollment (Anticipated): 40

Contacts and Locations

• Study Contact: Name: Andreea Fisus, MD; Phone Number: 01 91021-57564; Email: office@viros.at
• Study Contact Backup: Name: Manuel Ruiss, MSc.; Phone Number: 01 91021-57564; Email: office@viros.at

Study Locations

• Austria
  • Vienna, Austria, 1140
    • Recruiting
    • Vienna Institute for Research in Ocular Surgery (VIROS)
    • Contact: Andreea Fisus, MD; Phone Number: 01 91021-57564; Email: office@viros.at
    • Contact: Manuel Ruiss, MSc.; Phone Number: 01 91021-57564; Email: office@viros.at

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 105 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients undergoing cataract surgery

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Proliferation in an in-vitro model; An in-vitro model is used to study lens epithelial cell proliferation	Procedure: In-vitro model; In-vitro model of posterior capsule opacification by culturing the lens capsule

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Amount of proliferation of lens epithelial cells (LECs) in-vitro compared to in vivo in the same patient	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	24 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Prim. Prof. Dr. Oliver Findl, MBA

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2019
• Primary Completion (Anticipated): May 1, 2020
• Study Completion (Anticipated): January 1, 2021

Study Registration Dates

• First Submitted: February 26, 2019
• First Submitted That Met QC Criteria: February 26, 2019
• First Posted (Actual): February 28, 2019

Study Record Updates

• Last Update Posted (Actual): March 16, 2020
• Last Update Submitted That Met QC Criteria: March 13, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: Proliferation; Lens capsule
• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Cataract; Capsule Opacification
• Other Study ID Numbers: Proliferation

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No