LEC Proliferation in Vivo and In-vitro
Bilateral and Age-dependent Differences in Posterior Capsule Opacification in Vivo Compared to an In-vitro Mode
1 other identifier
observational
40
1 country
1
Brief Summary
Investigate the proliferative capacity of individual lens epithelium capsule specimens in vitro and correlate it to the risk of developing PCO
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jan 2019
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2019
CompletedFirst Submitted
Initial submission to the registry
February 26, 2019
CompletedFirst Posted
Study publicly available on registry
February 28, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2021
CompletedMarch 16, 2020
March 1, 2020
1.3 years
February 26, 2019
March 13, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
Amount of proliferation of LECs in-vitro in young and older patients
24 months
Amount of proliferation of LECs in-vitro between different forms of cataract
24 months
Study Arms (1)
Proliferation in an in-vitro model
An in-vitro model is used to study lens epithelial cell proliferation
Interventions
In-vitro model of posterior capsule opacification by culturing the lens capsule
Eligibility Criteria
Patients undergoing cataract surgery
You may qualify if:
- 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.
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Vienna Institute for Research in Ocular Surgery (VIROS)
Vienna, 1140, Austria
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
February 26, 2019
First Posted
February 28, 2019
Study Start
January 1, 2019
Primary Completion
May 1, 2020
Study Completion
January 1, 2021
Last Updated
March 16, 2020
Record last verified: 2020-03