Posterior Capsule OpacificationNCT03857685
LEC Proliferation in Vivo and In-vitro
An observational study of Posterior Capsule Opacification, run by Prim. Prof. Dr. Oliver Findl, MBA at 1 site in Austria.
Trial summary
Investigate the proliferative capacity of individual lens epithelium capsule specimens in vitro and correlate it to the risk of developing PCO Read more about this study
- Who is it for?
- Ages 21 to 105 years
- Conditions the study is for
- Posterior Capsule Opacification
- What is being tested?
- In-vitro model
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- How many people
- 40 participants
- Where
- 1 siteAustria
- Study dates
- 1 Jan 2019to 1 Jan 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 105 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing cataract surgery
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
Austria1 site, 1 recruiting
- Recruiting
Vienna Institute for Research in Ocular Surgery (VIROS)
Vienna, 1140
Andreea Fisus, MD, 01 91021-57564, office@viros.at
Manuel Ruiß, MSc., 01 91021-57564, office@viros.at
About this study
Official title: 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
Read the 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.
- Conditions
- Posterior Capsule Opacification
- Being tested
- In-vitro model
- Keywords
- Lens capsule, Proliferation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
In-vitro modelProcedure or surgery
In-vitro model of posterior capsule opacification by culturing the lens capsule
| Study group | Role | What they receive |
|---|---|---|
| Proliferation in an in-vitro model | An in-vitro model is used to study lens epithelial cell proliferation Receives: Procedure: In-vitro model |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 24 months
Secondary outcomes (2)
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
Measured: 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)
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2019
- Study start1 Jan 2019
- Primary completion1 May 2020 (estimated)
- Study completion1 Jan 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Posterior Capsule OpacificationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Prim. Prof. Dr. Oliver Findl, MBA
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Prim. Prof. Dr. Oliver Findl, MBA, Vienna Institute for Research in Ocular Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03857685
- Sponsor's protocol ID
- Proliferation
- Status last verified
- Mar 2020
- First submitted
- 26 Feb 2019
- Last updated
- 16 Mar 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bilateral and Age-dependent Differences in Posterior Capsule Opacification in Vivo Compared to an In-vitro Mode
- ClinicalTrials.gov ID
- NCT03857685
- Acronym / sponsor ID
- Proliferation
- Conditions
- Posterior Capsule Opacification
- Keywords
- Lens capsule, Proliferation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Prim. Prof. Dr. Oliver Findl, MBAUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 1 May 2020 (estimated)
- Study completion
- 1 Jan 2021 (estimated)
- First posted
- 28 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Proliferation in an in-vitro model | – | Procedure: In-vitro modelAn in-vitro model is used to study lens epithelial cell proliferation |
Who may qualify
- Ages
- 21 to 105 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing cataract surgery
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| In-vitro modelIn-vitro model of posterior capsule opacification by culturing the lens capsule | Procedure or surgery | Proliferation in an in-vitro model |
Primary outcome
Amount of proliferation of lens epithelial cells (LECs) in-vitro compared to in vivo in the same patient
Time frame: 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
2 secondary outcomes
Amount of proliferation of LECs in-vitro in young and older patients
Time frame: 24 months
Amount of proliferation of LECs in-vitro between different forms of cataract
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Posterior Capsule Opacification, run by Prim. Prof. Dr. Oliver Findl, MBA at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Andreea Fisus, MD (01 91021-57564, office@viros.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Amount of proliferation of lens epithelial cells (LECs) in-vitro compared to in vivo in the same patient (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2020.