Endothelial Cell Loss With Different Insertion DevicesNCT01284543
Study Comparing Tan EndoGlide With the Busin Glide for Insertion of the Donor Graft in DSAEK
A study testing Use of the Tan EndoGlide to insert donor graft and Busin Glide for delivery of the donor graft in people with Endothelial Cell Loss With Different Insertion Devices, run by University Health Network, Toronto at 1 site in Canada.
Trial summary
The Tan EndoGlide device results in less endothelial cell trauma during insertion of the donor corneal graft indicated by reduced endothelial cell loss at 1 year follow-up compared to the Busin glide. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Endothelial Cell Loss With Different Insertion Devices
- What is being tested?
- Use of the Tan EndoGlide to insert donor graft and Busin Glide for delivery of the donor graft
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2011to Jan 2012
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients presenting with corneal decompensation requiring DSAEK with or without cataract surgery for visual rehabilitation.
- Clinical diagnosis include endothelial cell dysfunction secondary to Fuchs endothelial dystrophy, pseudophakic or aphakic bullous keratopathy, failed penetrating keratoplasty or DSAEK, iridocorneal endothelial syndrome or trauma.
- Ability to understand the nature of the procedure and give full informed consent.
- Patients who are able to comply with the standard DSAEK follow-up protocol at the Toronto Western Hospital.
Who cannot join
- Patients with late stage corneal decompensation with stromal scarring unsuitable for DSAEK and therefore requiring penetrating keratoplasty.
- Patients with complex anterior segment pathology precluding successful DSAEK procedure.
- Patients not giving full informed consent to participate in the trial
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Toronto Western Hospital
Toronto, Ontario, M5B1L2
David S Rootman, MD, 1-416-545-1900, d.rootman@utoronto.ca
David S Rootman, MD
About this study
Official title: Randomized Prospective Study Comparing Tan EndoGlide With the Busin Glide for Insertion of the Donor Graft in Descemet Stripping Automated Endothelial Keratoplasty (DSAEK)
The Tan EndoGlide device results in less endothelial cell trauma during insertion of the donor corneal graft indicated by reduced endothelial cell loss at 1 year follow-up compared to the Busin glide.
- Being tested
- Use of the Tan EndoGlide to insert donor graft, Busin Glide for delivery of the donor graft
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Use of the Tan EndoGlide to insert donor graftDevice
Using the Tan EndoGlide to insert donor graft into the eye
Busin Glide for delivery of the donor graftDevice
Use of the forceps for delivery of the donor graft into the eye
| Study group | Role | What they receive |
|---|---|---|
| Busin glide delivery of donor graft | Active comparator | Use of the Busin glide to insert the donor graft Receives: Device: Busin Glide for delivery of the donor graft |
| Tan EndoGlide for insertion of the donor graft | Experimental | Use of the Tan EndoGlide for insertion of the donor graft Receives: Device: Use of the Tan EndoGlide to insert donor graft |
What is being measured
The primary outcome is the main question the study is designed to answer.
Endothelial cell counts at 1, 3, 6 and 12 months postoperatively
Measured: 1 year
Best corrected visual acuity at 1, 3, 6, and 12 months postoperatively
Measured: 1 year
Secondary outcomes (1)
Complications of surgery
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 posted27 Jan 2011 (estimated)
- Study startJan 2011
- Primary completionJan 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endothelial Cell Loss With Different Insertion DevicesStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01284543
- Sponsor's protocol ID
- REB-10-0631-B
- Status last verified
- Jan 2011
- First submitted
- 24 Jan 2011
- Last updated
- 27 Jan 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Prospective Study Comparing Tan EndoGlide With the Busin Glide for Insertion of the Donor Graft in Descemet Stripping Automated Endothelial Keratoplasty (DSAEK)
- ClinicalTrials.gov ID
- NCT01284543
- Acronym / sponsor ID
- REB-10-0631-B
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Jan 2012 (estimated)
- First posted
- 27 Jan 2011 (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 Tan EndoGlide device results in less endothelial cell trauma during insertion of the donor corneal graft indicated by reduced endothelial cell loss at 1 year follow-up compared to the Busin glide.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Busin glide delivery of donor graft | Active comparator | Device: Busin Glide for delivery of the donor graftUse of the Busin glide to insert the donor graft |
| Tan EndoGlide for insertion of the donor graft | Experimental | Device: Use of the Tan EndoGlide to insert donor graftUse of the Tan EndoGlide for insertion of the donor graft |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients presenting with corneal decompensation requiring DSAEK with or without cataract surgery for visual rehabilitation.
- Clinical diagnosis include endothelial cell dysfunction secondary to Fuchs endothelial dystrophy, pseudophakic or aphakic bullous keratopathy, failed penetrating keratoplasty or DSAEK, iridocorneal endothelial syndrome or trauma.
- Ability to understand the nature of the procedure and give full informed consent.
- Patients who are able to comply with the standard DSAEK follow-up protocol at the Toronto Western Hospital.
Key exclusion criteria (3 listed)
- Patients with late stage corneal decompensation with stromal scarring unsuitable for DSAEK and therefore requiring penetrating keratoplasty.
- Patients with complex anterior segment pathology precluding successful DSAEK procedure.
- Patients not giving full informed consent to participate in the trial
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 |
|---|---|---|
| Use of the Tan EndoGlide to insert donor graftUsing the Tan EndoGlide to insert donor graft into the eye | Device | Tan EndoGlide for insertion of the donor graft |
| Busin Glide for delivery of the donor graftUse of the forceps for delivery of the donor graft into the eye | Device | Busin glide delivery of donor graft |
Primary outcome
Endothelial cell counts at 1, 3, 6 and 12 months postoperatively
Time frame: 1 year
Best corrected visual acuity at 1, 3, 6, and 12 months postoperatively
Time frame: 1 year
1 secondary outcome
Complications of surgery
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2011.
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?
A study testing Use of the Tan EndoGlide to insert donor graft and Busin Glide for delivery of the donor graft in people with Endothelial Cell Loss With Different Insertion Devices, run by University Health Network, Toronto at 1 site in Canada.
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 4 inclusion and 3 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 27 Jan 2011. 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 Canada. 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 David S Rootman, MD (1-416-545-1900, d.rootman@utoronto.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Endothelial cell counts at 1, 3, 6 and 12 months postoperatively (time frame: 1 year). The study lists 2 primary outcomes in all. 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 27 Jan 2011.