Bullous KeratopathyNCT01122043
The SNEC DSAEK EndoGlide Clinical Trial
An observational study of Bullous Keratopathy, run by Singapore Eye Research Institute at 1 site in Singapore.
Trial summary
The purpose of this study is to determine the clinical safety and efficacy of the EndoGlide as a donor insertion device in DSAEK surgery. The investigators hypotheses is that the Endoglide will cause less endothelial damage compared to the investigators previous technique of glide insertion but will have the same low… Read more about this study
- Who is it for?
- Ages 21 to 90 years
- Conditions the study is for
- Bullous Keratopathy
- What is being tested?
- Endoglide
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 1 siteSingapore
- Study dates
- Jan 2010to Jan 2013
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with Bullous Keratopathy
Who may be able to join
- patients presenting with corneal decompensation or bullous keratopathy requiring corneal transplantation for visual restoration and pain relief
- Clinical diagnoses including post-surgical forms of corneal decompensation (all forms of pseudophakic and aphakic bullous keratopathy including TASS and irreversible Descemets detachment), post-laser corneal decompensation, Fuchs' and other forms of endothelial dystrophy, traumatic corneal decompensation, post-inflammatory corneal decompensation, etc.
- Mild to moderate forms of corneal decompensation
- patients who agree to study participation following full informed consent
- patients who agree to adhere to the standard SNEC clinical DSAEK protocol in terms of pre and postoperative investigations and follow-up visits up to 12 months
Who cannot join
- Severe forms or late stage presentation of corneal decompensation with severe corneal stromal scarring, unsuitable for DSAEK surgery as apposed to penetrating keratoplasty
- patients with complex anterior segment complications precluding a successful DSAEK procedure
- patients unkeen to participate in the clinical trial
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to determine the clinical safety and efficacy of the EndoGlide as a donor insertion device in DSAEK surgery. The investigators hypotheses is that the Endoglide will cause less endothelial damage compared to the investigators previous technique of glide insertion but will have the same low complication rate as the previous device. Hence the investigators aim to evaluate the surgical efficacy of the EndoGlide to enable consistent double coiling of the donor lenticule in DSAEK surgery with minimal endothelial touch. Evaluate ease of insertion of the EndoGlide through a 4 to 4.5mm scleral tunnel wound. Evaluate ability of the EndoGlide to consistently effect complete wound sealing, so as to stabilize anterior chamber with an AC maintainer in position. Evaluate ease of donor pull-through from the EndoGlide chamber into the AC and to evaluate spontaneous uncoiling of the donor in the AC. Evaluate clinical efficacy and safety outcomes in EndoGlide assisted DSAEK surgery in study patients with corneal decompensation requiring DSAEK surgery, in terms of postoperative visual acuity, primary graft failure rate, donor dislocation rate, endothelial cell loss, and deturgescence of the host cornea and donor lenticule as measured by corneal thickness parameters with the Visante AS-OCT. The investigators will perfprm a prospective Phase II clinical trial using the EndoGlide for donor insertion in 100 corneal patients referred to the SNEC Corneal Clinics of the study investigators with moderate degrees of corneal decompensation from a variety of disorders which require DSAEK corneal transplantation surgery, with or without concurrent cataract surgery, to restore visual acuity.
- Conditions
- Bullous Keratopathy
- Being tested
- Endoglide
- Keywords
- Endoglide, Endothelial Keratoplasty, Donor Insertion, DSAEK, Corneal Transplant, Patients with Bullous Keratopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EndoglideDevice
Device
| Study group | Role | What they receive |
|---|---|---|
| Endoglide | Patients with moderate degrees of corneal decompensation from a variety of disorders which require DSAEK corneal transplantation surgery, with or without concurrent cataract surgery, to restore visual acuity. Receives: Device: Endoglide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Graft Failure
Measured: One month
Secondary outcomes (2)
Donor Graft Dislocation
Measured: One week
Endothelial Cell loss
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 posted12 May 2010 (estimated)
- Study startJan 2010
- Primary completionJan 2012
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bullous KeratopathyStudies 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
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Singapore Eye Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- UK Network Medical
- Responsible party
- Principal investigator, Jodhbir Mehta, Singapore Eye Research Institute
- Investigators
- Donald Tan, MD FRCS, Principal investigator, Singapore National Eye Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01122043
- Sponsor's protocol ID
- R664/14/2009
- Other IDs
- Other grant
- Status last verified
- Jul 2016
- First submitted
- 10 May 2010
- Last updated
- 20 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Khor WB, Mehta JS, Tan DT. Descemet stripping automated endothelial keratoplasty with a graft insertion device: surgical technique and early clinical results. Am J Ophthalmol. 2011 Feb;151(2):223-32.e2. doi: 10.1016/j.ajo.2010.08.027. Epub 2010 Dec 18.
PubMed 21168813
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The SNEC DSAEK EndoGlide Clinical Trial
- ClinicalTrials.gov ID
- NCT01122043
- Acronym / sponsor ID
- R664/14/2009
- Conditions
- Bullous Keratopathy
- Keywords
- Endoglide, Endothelial Keratoplasty, Donor Insertion, DSAEK, Corneal Transplant, Patients with Bullous Keratopathy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Singapore Eye Research InstituteUniversity, hospital or other
- Collaborators
- UK Network Medical
- Study start
- Jan 2010
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 12 May 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.
The purpose of this study is to determine the clinical safety and efficacy of the EndoGlide as a donor insertion device in DSAEK surgery. The investigators hypotheses is that the Endoglide will cause less endothelial damage compared to the investigators previous technique of glide insertion but will have the same low complication rate as the previous device. Hence the investigators aim to evaluate the surgical efficacy of the EndoGlide to enable consistent double coiling of the donor lenticule in DSAEK surgery with minimal endothelial touch. Evaluate ease of insertion of the EndoGlide through a 4 to 4.5mm scleral tunnel wound. Evaluate ability of the EndoGlide to consistently effect complete wound sealing, so as to stabilize anterior chamber with an AC maintainer in position. Evaluate ease of donor pull-through from the EndoGlide chamber into the AC and to evaluate spontaneous uncoiling of the donor in the AC. Evaluate clinical efficacy and safety outcomes in EndoGlide assisted DSAEK surgery in study patients with corneal decompensation requiring DSAEK surgery, in terms of postoperative visual acuity, primary graft failure rate, donor dislocation rate, endothelial cell loss, and deturgescence of the host cornea and donor lenticule as measured by corneal thickness parameters with the Visante AS-OCT. The investigators will perfprm a prospective Phase II clinical trial using the EndoGlide for donor insertion in 100 corneal patients referred to the SNEC Corneal Clinics of the study investigators with moderate degrees of corneal decompensation from a variety of disorders which require DSAEK corneal transplantation surgery, with or without concurrent cataract surgery, to restore visual acuity.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Endoglide | – | Device: EndoglidePatients with moderate degrees of corneal decompensation from a variety of disorders which require DSAEK corneal transplantation surgery, with or without concurrent cataract surgery, to restore visual acuity. |
Who may qualify
- Ages
- 21 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with Bullous Keratopathy
Key inclusion criteria (5 listed)
- patients presenting with corneal decompensation or bullous keratopathy requiring corneal transplantation for visual restoration and pain relief
- Clinical diagnoses including post-surgical forms of corneal decompensation (all forms of pseudophakic and aphakic bullous keratopathy including TASS and irreversible Descemets detachment), post-laser corneal decompensation, Fuchs' and other forms of endothelial dystrophy, traumatic corneal decompensation, post-inflammatory corneal decompensation, etc.
- Mild to moderate forms of corneal decompensation
- patients who agree to study participation following full informed consent
- patients who agree to adhere to the standard SNEC clinical DSAEK protocol in terms of pre and postoperative investigations and follow-up visits up to 12 months
Key exclusion criteria (3 listed)
- Severe forms or late stage presentation of corneal decompensation with severe corneal stromal scarring, unsuitable for DSAEK surgery as apposed to penetrating keratoplasty
- patients with complex anterior segment complications precluding a successful DSAEK procedure
- patients unkeen to participate in the clinical 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 |
|---|---|---|
| EndoglideDevice | Device | Endoglide |
Primary outcome
Primary Graft Failure
Time frame: One month
2 secondary outcomes
Donor Graft Dislocation
Time frame: One week
Endothelial Cell loss
Time frame: One year
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 20 Jul 2016.
- Derived from this study: PubMed 21168813Khor WB, Mehta JS, Tan DT. Descemet stripping automated endothelial keratoplasty with a graft insertion device: surgical technique and early clinical results. Am J Ophthalmol. 2011 Feb;151(2):223-32.e2. doi: 10.1016/j.ajo.2010.08.027. Epub 2010 Dec 18.
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AURN001 Efficacy in Participants With Corneal Edema Secondary to Corneal Endothelial Dysfunction
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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.
Donald Tan, MD FRCS principal investigator
Singapore National Eye Centre
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 Bullous Keratopathy, run by Singapore Eye Research Institute at 1 site in Singapore.
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 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: finished, as of the sponsor's last update on 20 Jul 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 Singapore. 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?
Primary Graft Failure (time frame: One month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01122043, which also lists 1 linked publication.
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 20 Jul 2016.