LEC Proliferation in Vivo and In-vitro

Posterior Capsule Opacification Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03857685
• Other study ID #: Proliferation
• Status: Recruiting
• Start date: January 1, 2019
• Est. completion date: January 1, 2021

Study information

• Verified date: March 2020
• Source: Vienna Institute for Research in Ocular Surgery
• Contact: Andreea Fisus, MD
• Phone: 01 91021-57564
• Email: office[@]viros.at
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: January 1, 2021
• Est. primary completion date: May 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 105 Years

Eligibility

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).

Related Conditions & MeSH terms

• Capsule Opacification
• Posterior Capsule Opacification

Intervention

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

Locations

Country	Name	City	State
Austria	Vienna Institute for Research in Ocular Surgery (VIROS)	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Prim. Prof. Dr. Oliver Findl, MBA

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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