Rhegmatogenous Retinal DetachmentNCT02185469
Corneal Endothelial Cell Loss After Pneumatic Retinopexy for the Repair of Primary Rhegmatogenous Retinal Detachment
A study testing Pneumatic retinopexy, vitrectomy and sulfur hexafluoride (SF6) in people with Rhegmatogenous Retinal Detachment, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
Trial summary
There are multiple ways to treat retinal detachment, the aim of this study is to compare the amount of corneal endothelial cell loss after pneumatic retinopexy in comparison to vitrectomy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rhegmatogenous Retinal Detachment
- What is being tested?
- Pneumatic retinopexy, vitrectomy and sulfur hexafluoride (SF6)
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- Jul 2014to Jul 2015
- 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
- Age more than 18 years old.
- Patients with rhegmatogenous retinal detachment undergoing pneumatic retinopexy and pars plana vitrectomy.
- Patients on which specular microscopy and IOLMaster® can be performed without delaying their treatment (availability of a qualified operator).
- Decision makers able to give informed consent.
Who cannot join
- Unable to attend follow-up visits.
- History of previous intraocular surgery in surgical eye, except cataract extraction by phacoemulsification.
- Aphakia in surgical eye.
- Presence of an anterior chamber intraocular lens in surgical eye.
- Need for cryotherapy to treat the retinal break.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N 3M5
Charlene Muller, RN, PHN,CCRP, 416-480-5091, charlene.muller@sunnybrook.ca
Peter Kertes, MD, CM, FRCSC
About this study
There are multiple ways to treat retinal detachment, the aim of this study is to compare the amount of corneal endothelial cell loss after pneumatic retinopexy in comparison to vitrectomy.
Read the detailed description
Retinal detachment is a separation of the neurosensory retina from the retinal pigment epithelium. The most common form is rhegmatogenous retinal detachment, which occurs as the result of a full-thickness retinal break. There are three major techniques available to repair the detachment: scleral buckling, primary vitrectomy, and pneumatic retinopexy. At our institution, pneumatic retinopexy is the technique most commonly employed for primary repair. Pneumatic retinopexy is a minimally invasive surgery that involves injection of an intravitreal gas bubble to tamponade the causative retinal tear(s) and cryotherapy or laser photocoagulation to create a permanent chorioretinal adhesion.
Endothelial cells pumping function is essential to keep the cornea in a relatively dehydrated state that allows optical clarity. Corneal endothelial damage has been associated with almost all types of intraocular surgery. Cell loss due to vitrectomy in phakic eyes varies between 0.4 and 2.8%. , , , , During pars plana vitrectomy, all manipulation take place in the vitreous cavity; a certain distance from the corneal endothelium. Cataract extraction by phacoemulsification results in greater endothelial cell loss (4-18%), because of the greater proximity to the corneal endothelium during manipulation and direct damage from the use of ultrasound. To our knowledge, corneal endothelial cell loss after pneumatic retinopexy has never been studied. Corneal endothelium can be damaged during pneumatic retinopexy because an anterior paracentesis is performed before the gas injection. A 5/8-in 25-gauge needle is used to withdraw 0.3 to 0.35 ml of aqueous fluid form the anterior chamber. The procedure is invariably accompanied by a certain degree of shallowing of the anterior chamber. We postulate that endothelial cell damage can result from the direct contact of the needle tip with the corneal endothelium during wound creation and by inadvertent contact during shallowing of the anterior chamber.
A standard method of endothelial cell analysis used worldwide is specular microscopy. Specular microscopy is a non-invasive technique to access the structure and function of the corneal endothelium by permitting visualization of the corneal endothelial mosaic. From the areas of the cornea measured with specular microscopy, an estimate of endothelial cell density can be made.
- Conditions
- Rhegmatogenous Retinal Detachment
- Being tested
- Pneumatic retinopexy, vitrectomy, sulfur hexafluoride (SF6), 5/8-in 25-gauge needle, laser
- Keywords
- Corneal Endothelial Cell Loss, pneumatic retinopexy, vitrectomy
- Medical subject headings
- Corneal Endothelial Cell Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pneumatic retinopexyProcedure or surgery
First, a 5/8-in 25-gauge needle will be used to perform an anterior chamber paracentesis, aiming to withdraw a minimum of 0.3 ml of aqueous fluid form the anterior chamber. Then, sulfur hexafluoride (SF6) will be injected in the vitreous cavity. The total volume of gas injected will exceed by 0.3 ml the amount of fluid withdrawn by the anterior chamber paracentesis (ex: 0.6 ml of SF6 would be injected after having withdrawn 0.3 ml). The laser retinopexy will be performed 48 hours later with laser.
vitrectomyProcedure or surgery
Under certain circumstances, pneumatic retinopexy can't be considered as a primary treatment for rhegmatogenous retinal detachment. In these cases, the patient will be booked for urgent 25 G vitrectomy with intraoperative laser retinopexy and gas injection to treat retinal detachment
sulfur hexafluoride (SF6)Drug
5/8-in 25-gauge needleDevice
laserDevice
intraoperative laser retinopexy
| Study group | Role | What they receive |
|---|---|---|
| pneumatic retinopexy group | Active comparator | First, a 5/8-in 25-gauge needle will be used to perform an anterior chamber paracentesis, aiming to withdraw a minimum of 0.3 ml of aqueous fluid form the anterior chamber. Then, sulfur hexafluoride (SF6) will be injected in the vitreous cavity. The total volume of gas injected will exceed by 0.3 ml the amount of fluid withdrawn by the anterior chamber paracentesis (ex: 0.6 ml of SF6 would be injected after having withdrawn 0.3 ml). The laser retinopexy will be performed 48 hours later with laser. Receives: Procedure: Pneumatic retinopexy; Drug: sulfur hexafluoride (SF6); Device: 5/8-in 25-gauge needle; Device: laser |
| vitrectomy group | Active comparator | Under certain circumstances, pneumatic retinopexy can't be considered as a primary treatment for rhegmatogenous retinal detachment. In these cases, the patient will be booked for urgent 25 G vitrectomy with intraoperative laser retinopexy and gas injection to treat retinal detachment Receives: Procedure: vitrectomy; Device: laser |
What is being measured
The primary outcome is the main question the study is designed to answer.
Endothelial cells count as measured by specular microscopy
Measured: at 3 and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2014 (estimated)
- Study startJul 2014
- Primary completionJun 2015 (estimated)
- Study completionJul 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rhegmatogenous Retinal DetachmentStudies of the same condition, open and under way.
- More trials run by Sunnybrook Health Sciences CentreThe 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sunnybrook Health Sciences Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Peter Kertes, Sunnybrook Health Sciences Centre
- Investigators
- Peter Kertes, MD, CM, FRCSC, Principal investigator, Sunnybrook Health Sciences Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02185469
- Sponsor's protocol ID
- PRECC001
- Status last verified
- Jul 2014
- First submitted
- 9 Jun 2014
- Last updated
- 9 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Corneal Endothelial Cell Loss After Pneumatic Retinopexy for the Repair of Primary Rhegmatogenous Retinal Detachment
- ClinicalTrials.gov ID
- NCT02185469
- Acronym / sponsor ID
- PRECC001
- Conditions
- Rhegmatogenous Retinal Detachment
- Keywords
- Corneal Endothelial Cell Loss, pneumatic retinopexy, vitrectomy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Sunnybrook Health Sciences CentreUniversity, hospital or other
- Study start
- Jul 2014
- Primary completion
- Jun 2015 (estimated)
- Study completion
- Jul 2015 (estimated)
- First posted
- 9 Jul 2014 (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.
There are multiple ways to treat retinal detachment, the aim of this study is to compare the amount of corneal endothelial cell loss after pneumatic retinopexy in comparison to vitrectomy.
Detailed description
Retinal detachment is a separation of the neurosensory retina from the retinal pigment epithelium. The most common form is rhegmatogenous retinal detachment, which occurs as the result of a full-thickness retinal break. There are three major techniques available to repair the detachment: scleral buckling, primary vitrectomy, and pneumatic retinopexy. At our institution, pneumatic retinopexy is the technique most commonly employed for primary repair. Pneumatic retinopexy is a minimally invasive surgery that involves injection of an intravitreal gas bubble to tamponade the causative retinal tear(s) and cryotherapy or laser photocoagulation to create a permanent chorioretinal adhesion.
Endothelial cells pumping function is essential to keep the cornea in a relatively dehydrated state that allows optical clarity. Corneal endothelial damage has been associated with almost all types of intraocular surgery. Cell loss due to vitrectomy in phakic eyes varies between 0.4 and 2.8%. , , , , During pars plana vitrectomy, all manipulation take place in the vitreous cavity; a certain distance from the corneal endothelium. Cataract extraction by phacoemulsification results in greater endothelial cell loss (4-18%), because of the greater proximity to the corneal endothelium during manipulation and direct damage from the use of ultrasound. To our knowledge, corneal endothelial cell loss after pneumatic retinopexy has never been studied. Corneal endothelium can be damaged during pneumatic retinopexy because an anterior paracentesis is performed before the gas injection. A 5/8-in 25-gauge needle is used to withdraw 0.3 to 0.35 ml of aqueous fluid form the anterior chamber. The procedure is invariably accompanied by a certain degree of shallowing of the anterior chamber. We postulate that endothelial cell damage can result from the direct contact of the needle tip with the corneal endothelium during wound creation and by inadvertent contact during shallowing of the anterior chamber.
A standard method of endothelial cell analysis used worldwide is specular microscopy. Specular microscopy is a non-invasive technique to access the structure and function of the corneal endothelium by permitting visualization of the corneal endothelial mosaic. From the areas of the cornea measured with specular microscopy, an estimate of endothelial cell density can be made.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| pneumatic retinopexy group | Active comparator | Procedure: Pneumatic retinopexy, Drug: sulfur hexafluoride (SF6), Device: 5/8-in 25-gauge needle, Device: laserFirst, a 5/8-in 25-gauge needle will be used to perform an anterior chamber paracentesis, aiming to withdraw a minimum of 0.3 ml of aqueous fluid form the anterior chamber. Then, sulfur hexafluoride (SF6) will be injected in the vitreous cavity. The total volume of gas injected will exceed by 0.3 ml the amount of fluid withdrawn by the anterior chamber paracentesis (ex: 0.6 ml of SF6 would be injected after having withdrawn 0.3 ml). The laser retinopexy will be performed 48 hours later with laser. |
| vitrectomy group | Active comparator | Procedure: vitrectomy, Device: laserUnder certain circumstances, pneumatic retinopexy can't be considered as a primary treatment for rhegmatogenous retinal detachment. In these cases, the patient will be booked for urgent 25 G vitrectomy with intraoperative laser retinopexy and gas injection to treat retinal detachment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age more than 18 years old.
- Patients with rhegmatogenous retinal detachment undergoing pneumatic retinopexy and pars plana vitrectomy.
- Patients on which specular microscopy and IOLMaster® can be performed without delaying their treatment (availability of a qualified operator).
- Decision makers able to give informed consent.
Key exclusion criteria (5 listed)
- Unable to attend follow-up visits.
- History of previous intraocular surgery in surgical eye, except cataract extraction by phacoemulsification.
- Aphakia in surgical eye.
- Presence of an anterior chamber intraocular lens in surgical eye.
- Need for cryotherapy to treat the retinal break.
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 |
|---|---|---|
| Pneumatic retinopexyFirst, a 5/8-in 25-gauge needle will be used to perform an anterior chamber paracentesis, aiming to withdraw a minimum of 0.3 ml of aqueous fluid form the anterior chamber. Then, sulfur hexafluoride (SF6) will be injected in the vitreous cavity. The total volume of gas injected will exceed by 0.3 ml the amount of fluid withdrawn by the anterior chamber paracentesis (ex: 0.6 ml of SF6 would be injected after having withdrawn 0.3 ml). The laser retinopexy will be performed 48 hours later with laser. | Procedure or surgery | pneumatic retinopexy group |
| vitrectomyUnder certain circumstances, pneumatic retinopexy can't be considered as a primary treatment for rhegmatogenous retinal detachment. In these cases, the patient will be booked for urgent 25 G vitrectomy with intraoperative laser retinopexy and gas injection to treat retinal detachment | Procedure or surgery | vitrectomy group |
| sulfur hexafluoride (SF6) | Drug | pneumatic retinopexy group |
| 5/8-in 25-gauge needle | Device | pneumatic retinopexy group |
| laserintraoperative laser retinopexy | Device | pneumatic retinopexy group, vitrectomy group |
Primary outcome
Endothelial cells count as measured by specular microscopy
Time frame: at 3 and 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2014.
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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.
Peter Kertes, MD, CM, FRCSC principal investigator
Sunnybrook Health Sciences Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pneumatic retinopexy, vitrectomy and sulfur hexafluoride (SF6) in people with Rhegmatogenous Retinal Detachment, run by Sunnybrook Health Sciences Centre 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 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: status not confirmed, as of the sponsor's last update on 9 Jul 2014. 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 Charlene Muller, RN, PHN,CCRP (416-480-5091, charlene.muller@sunnybrook.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Endothelial cells count as measured by specular microscopy (time frame: at 3 and 6 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 9 Jul 2014.