LEC Proliferation in Vivo and In-vitro

NCT ID: NCT03857685

Last Updated: 2020-03-16

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

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Recruitment Status

UNKNOWN

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-01-01

Study Completion Date

2021-01-01

Brief Summary

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

Detailed Description

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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.

Conditions

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Posterior Capsule Opacification

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Proliferation in an in-vitro model

An in-vitro model is used to study lens epithelial cell proliferation

In-vitro model

Intervention Type PROCEDURE

In-vitro model of posterior capsule opacification by culturing the lens capsule

Interventions

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In-vitro model

In-vitro model of posterior capsule opacification by culturing the lens capsule

Intervention Type PROCEDURE

Eligibility Criteria

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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).
Minimum Eligible Age

21 Years

Maximum Eligible Age

105 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Prim. Prof. Dr. Oliver Findl, MBA

OTHER

Sponsor Role lead

Responsible Party

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Prim. Prof. Dr. Oliver Findl, MBA

Principal Investigator

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Vienna Institute for Research in Ocular Surgery (VIROS)

Vienna, , Austria

Site Status RECRUITING

Countries

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Austria

Central Contacts

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Andreea Fisus, MD

Role: CONTACT

01 91021-57564

Manuel Ruiß, MSc.

Role: CONTACT

01 91021-57564

Facility Contacts

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Andreea Fisus, MD

Role: primary

01 91021-57564

Manuel Ruiß, MSc.

Role: backup

01 91021-57564

Other Identifiers

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Proliferation

Identifier Type: -

Identifier Source: org_study_id

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