Congenital CataractNCT01136473
Mechanism of Aphakic and Pseudophakic Glaucoma in Pediatric Patients
An observational study of Congenital Cataract and Aphakic or Pseudophakic Glaucoma, run by Carmel Medical Center at 1 site in Israel.
Trial summary
In cell cultures, lens epithelial cells and trabecular meshwork cells will be exposed to aqueous humor from pediatric eyes undergoing cataract removal surgery. Cytokine analysis of candidate factors will be performed before and after exposure to lens epithelial. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Congenital Cataract, Aphakic or Pseudophakic Glaucoma
- How many people
- 40 participants
- Where
- 1 siteIsrael
- Study dates
- Jul 2011to Sep 2014
- 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 Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: children 0-18
Who may be able to join
- children with congenital cataract and are going to do removal surgery
- children with aphakic or pseudophakic glaucoma and are going to do glaucoma surgery
- both of parents are able to sign the INFORMED CONSENT FORM
Who cannot join
- patients with other eye diseases apart from congenital cataract(in children with congenital cataract) and aphakic or pseudophakic glaucoma (in children with aphakic or pseudophakic glaucoma)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Mechanism of Aphakic and Pseudophakic Glaucoma in Pediatric Patients: Exploring the Pathophysiology Through Lens Epithelial Cell Culture and Isolation of Candidate Factors From Aqueous Humor
In cell cultures, lens epithelial cells and trabecular meshwork cells will be exposed to aqueous humor from pediatric eyes undergoing cataract removal surgery. Cytokine analysis of candidate factors will be performed before and after exposure to lens epithelial.
Read the detailed description
Aqueous from the anterior chamber will be withdrawn before surgery. Then the lens capsule will be opened (capsulorhexis) and removed. The lens material will be removed. All 3 components will be sent to the lab.
Lens epithelial cells will be isolated and will be used in a co-culture setup with trabecular cells to investigate the interactions between lens cells and trabecular cells. Understanding the interaction between young and adult lens cells on trabecular cell will shed light on mechanism of infantile aphakic glaucoma.
Aqueous humor taken out before cataract surgery and before glaucoma operation of aphakic eyes will be used for analysis of growth factor and cytokines in the Aphakic eye using proteins membrane arrays. Eyes before cataract surgery will be used as controls. Such analysis will shed light on the possible factors affecting trabecular cells in aphakic eye.
- Keywords
- congenital cataract, aphakic, pseudophakic glaucoma, pediatric patients
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| congenital cataract or aphakic glaucoma | children with congenital cataract or aphakic glaucoma |
What is being measured
The primary outcome is the main question the study is designed to answer.
cell culture
In cell cultures, lens epithelial cells and trabecular meshwork cells will be exposed to aqueous humor from pediatric eyes undergoing cataract removal surgery. Cytokine analysis of candidate factors will be performed before and after exposure to lens epithelial.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2010 (estimated)
- Study startJul 2011
- Primary completionSep 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congenital CataractStudies 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Carmel Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Orna Geyer, Carmel Medical Center
- Investigators
- Orna Geyer, Prof, Principal investigator, Carmel Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01136473
- Sponsor's protocol ID
- CMC-10-0035-CTIL
- Status last verified
- Feb 2015
- First submitted
- 27 May 2010
- Last updated
- 24 Feb 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mechanism of Aphakic and Pseudophakic Glaucoma in Pediatric Patients: Exploring the Pathophysiology Through Lens Epithelial Cell Culture and Isolation of Candidate Factors From Aqueous Humor
- ClinicalTrials.gov ID
- NCT01136473
- Acronym / sponsor ID
- CMC-10-0035-CTIL
- Keywords
- congenital cataract, aphakic, pseudophakic glaucoma, pediatric patients
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Carmel Medical CenterUniversity, hospital or other
- Study start
- Jul 2011
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 3 Jun 2010 (estimated)
- 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.
In cell cultures, lens epithelial cells and trabecular meshwork cells will be exposed to aqueous humor from pediatric eyes undergoing cataract removal surgery. Cytokine analysis of candidate factors will be performed before and after exposure to lens epithelial.
Detailed description
Aqueous from the anterior chamber will be withdrawn before surgery. Then the lens capsule will be opened (capsulorhexis) and removed. The lens material will be removed. All 3 components will be sent to the lab.
Lens epithelial cells will be isolated and will be used in a co-culture setup with trabecular cells to investigate the interactions between lens cells and trabecular cells. Understanding the interaction between young and adult lens cells on trabecular cell will shed light on mechanism of infantile aphakic glaucoma.
Aqueous humor taken out before cataract surgery and before glaucoma operation of aphakic eyes will be used for analysis of growth factor and cytokines in the Aphakic eye using proteins membrane arrays. Eyes before cataract surgery will be used as controls. Such analysis will shed light on the possible factors affecting trabecular cells in aphakic eye.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| congenital cataract or aphakic glaucoma | – | –children with congenital cataract or aphakic glaucoma |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- children 0-18
Key inclusion criteria (3 listed)
- children with congenital cataract and are going to do removal surgery
- children with aphakic or pseudophakic glaucoma and are going to do glaucoma surgery
- both of parents are able to sign the INFORMED CONSENT FORM
Key exclusion criteria (1 listed)
- patients with other eye diseases apart from congenital cataract(in children with congenital cataract) and aphakic or pseudophakic glaucoma (in children with aphakic or pseudophakic glaucoma)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
cell culture
Time frame: one year
In cell cultures, lens epithelial cells and trabecular meshwork cells will be exposed to aqueous humor from pediatric eyes undergoing cataract removal surgery. Cytokine analysis of candidate factors will be performed before and after exposure to lens epithelial.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2015.
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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.
Orna Geyer, Prof principal investigator
Carmel Medical Center
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 Congenital Cataract and Aphakic or Pseudophakic Glaucoma, run by Carmel Medical Center at 1 site in Israel.
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 3 inclusion and 1 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: finished, as of the sponsor's last update on 24 Feb 2015. 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 Israel. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
cell culture (time frame: one year). 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 24 Feb 2015; AzTrials last refreshed its copy on 8 Nov 2026.