GlaucomaNCT02524431
The Changes Within the Cells of the Drainage System of the Eye in Patients With Glaucoma
A study testing Collection of trabecular meshwork tissue during surgery in people with Glaucoma, run by Wills Eye at 1 site in United States.
Trial summary
The purpose of this study is to try to identify the cause of damage to the drainage system of the eye (the trabecular meshwork). Damage to this system may cause elevation in the pressure within the eye and thereby damage to the optic nerve and the vision. Read more about this study
- Who is it for?
- Ages 21 to 80 years
- Conditions the study is for
- Glaucoma
- What is being tested?
- Collection of trabecular meshwork tissue during surgery
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2014to Jan 2016
- Phase
- Interventional
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Minimum 2-year diagnosis of POAG
- Moderate to advanced stage of the disease
- DDLS stages 5 through 10 with visual field loss
- Age between 21 and 80 years
- Planned trabeculectomy with or without concomitant cataract surgery
Who cannot join
- Age ≤ 20 years old
- Any other type of glaucoma other than POAG
- Patients who had undergone selective laser trabeculoplasty (SLT) or argon laser trabeculoplasty (ALT)
- Patients with history of ocular trauma
- Patients with previous eye surgery will be excluded both from the study and the control groups
Trial locations and contacts
1 site in 1 country.
United States1 site
Wills Eye Hospital
Philadelphia, Pennsylvania, 19107
About this study
Official title: The Changes of Mitochondrial Dynamics and the Molecular Mechanisms in the Trabecular Meshwork of Patients With Glaucoma
The purpose of this study is to try to identify the cause of damage to the drainage system of the eye (the trabecular meshwork). Damage to this system may cause elevation in the pressure within the eye and thereby damage to the optic nerve and the vision.
Read the detailed description
During a routine trabeculectomy surgery, a corneo-scleral block that includes TM tissue will be collected at the operating room. This tissue is routinely removed during every trabeculectomy surgery. The tissue will be stored immediately in normal saline at 4 degrees Celsius, and walked directly to the Jefferson Center for Translational Medicine at Thomas Jefferson University by the Wills eye glaucoma research fellow. TM tissue will be identified using light microscope base on TM cell pigmentation. The ocular tissue will be fixed and placed in pre-cooled fixative on ice for 1 hour. The lengths of mitochondrial cross sections at the longest extent will be measured under electron microscopy (EM) in order to identify the mitochondrial dynamics. Quantitative Polymerase Chain Reaction (qPCR) will be done to identify proteins responsible for mitochondrial fusion.
- Conditions
- Glaucoma
- Being tested
- Collection of trabecular meshwork tissue during surgery
- Keywords
- Mitochondria, trabeculectomy, trabecular meshwork, Glaucoma surgery
- Medical subject headings
- Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collection of trabecular meshwork tissue during surgeryOther
Tissue is collected during surgery at Wills Eye and then processed at thomas jefferson to identify the trabecular meshwork using light microscope. The ocular tissue will be fixed and the mitochondrial cross sections at the longest extent will be measured under electron microscopy (EM) in order to identify the mitochondrial dynamics. Quantitative Polymerase Chain Reaction (qPCR) will be done to identify proteins responsible for mitochondrial fusion.
| Study group | Role | What they receive |
|---|---|---|
| Glaucoma subjects | Active comparator | During glaucoma surgery, collection of trabecular meshwork tissue during surgery that is not needed is cut away from the surgical site. The physician will keep this tissue for analysis by the researchers at Wills Eye Hospital and Thomas Jefferson University Center for Translational Medicine. Receives: Other: Collection of trabecular meshwork tissue during surgery |
| Control cadaver eyes | Active comparator | control cadaver eye are ordered and the collection of trabecular meshwork tissue during surgery and is processed at Thomas Jefferson University Receives: Other: Collection of trabecular meshwork tissue during surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
3-D EM tomography for mitochondria obtained from sample tissue
Measured: 1 year
Secondary outcomes (1)
Gene expression of Drp1
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2015 (estimated)
- Study startNov 2014
- Primary completionJan 2016
- Study completionJan 2016
Why it stopped: Unable to obtain mitochondrial samples
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlaucomaStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wills Eye
- Sponsor type
- University, hospital or other
- Collaborators
- Thomas Jefferson University
- Responsible party
- Principal investigator, George L. Spaeth MD, Wills Eye
- Investigators
- George Spaeth, MD, Principal investigator, Wills Eye Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02524431
- Sponsor's protocol ID
- 14-430E
- Status last verified
- Nov 2016
- First submitted
- 6 Aug 2015
- Last updated
- 21 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Changes of Mitochondrial Dynamics and the Molecular Mechanisms in the Trabecular Meshwork of Patients With Glaucoma
- ClinicalTrials.gov ID
- NCT02524431
- Acronym / sponsor ID
- 14-430E
- Conditions
- Glaucoma
- Keywords
- Mitochondria, trabeculectomy, trabecular meshwork, Glaucoma surgery
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Unable to obtain mitochondrial samples
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Wills EyeUniversity, hospital or other
- Collaborators
- Thomas Jefferson University
- Study start
- Nov 2014
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 14 Aug 2015 (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.
The purpose of this study is to try to identify the cause of damage to the drainage system of the eye (the trabecular meshwork). Damage to this system may cause elevation in the pressure within the eye and thereby damage to the optic nerve and the vision.
Detailed description
During a routine trabeculectomy surgery, a corneo-scleral block that includes TM tissue will be collected at the operating room. This tissue is routinely removed during every trabeculectomy surgery. The tissue will be stored immediately in normal saline at 4 degrees Celsius, and walked directly to the Jefferson Center for Translational Medicine at Thomas Jefferson University by the Wills eye glaucoma research fellow. TM tissue will be identified using light microscope base on TM cell pigmentation. The ocular tissue will be fixed and placed in pre-cooled fixative on ice for 1 hour. The lengths of mitochondrial cross sections at the longest extent will be measured under electron microscopy (EM) in order to identify the mitochondrial dynamics. Quantitative Polymerase Chain Reaction (qPCR) will be done to identify proteins responsible for mitochondrial fusion.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Glaucoma subjects | Active comparator | Other: Collection of trabecular meshwork tissue during surgeryDuring glaucoma surgery, collection of trabecular meshwork tissue during surgery that is not needed is cut away from the surgical site. The physician will keep this tissue for analysis by the researchers at Wills Eye Hospital and Thomas Jefferson University Center for Translational Medicine. |
| Control cadaver eyes | Active comparator | Other: Collection of trabecular meshwork tissue during surgerycontrol cadaver eye are ordered and the collection of trabecular meshwork tissue during surgery and is processed at Thomas Jefferson University |
Who may qualify
- Ages
- 21 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Minimum 2-year diagnosis of POAG
- Moderate to advanced stage of the disease
- DDLS stages 5 through 10 with visual field loss
- Age between 21 and 80 years
- Planned trabeculectomy with or without concomitant cataract surgery
Key exclusion criteria (5 listed)
- Age ≤ 20 years old
- Any other type of glaucoma other than POAG
- Patients who had undergone selective laser trabeculoplasty (SLT) or argon laser trabeculoplasty (ALT)
- Patients with history of ocular trauma
- Patients with previous eye surgery will be excluded both from the study and the control groups
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 |
|---|---|---|
| Collection of trabecular meshwork tissue during surgeryTissue is collected during surgery at Wills Eye and then processed at thomas jefferson to identify the trabecular meshwork using light microscope. The ocular tissue will be fixed and the mitochondrial cross sections at the longest extent will be measured under electron microscopy (EM) in order to identify the mitochondrial dynamics. Quantitative Polymerase Chain Reaction (qPCR) will be done to identify proteins responsible for mitochondrial fusion. | Other | Control cadaver eyes, Glaucoma subjects |
Primary outcome
3-D EM tomography for mitochondria obtained from sample tissue
Time frame: 1 year
1 secondary outcome
Gene expression of Drp1
Time frame: 1 year
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2016.
- Individual participant dataSharing planned: Yes
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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.
George Spaeth, MD principal investigator
Wills Eye Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Collection of trabecular meshwork tissue during surgery in people with Glaucoma, run by Wills Eye at 1 site in United States.
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 5 inclusion and 5 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: withdrawn, as of the sponsor's last update on 21 Nov 2016. 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 United States. 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 was withdrawn before enrolling participants, so there are no results.
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?
3-D EM tomography for mitochondria obtained from sample tissue (time frame: 1 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 21 Nov 2016.