search
Back to results

Corneal Endothelial Cell Loss After Pneumatic Retinopexy for the Repair of Primary Rhegmatogenous Retinal Detachment

Primary Purpose

Rhegmatogenous Retinal Detachment

Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Pneumatic retinopexy
vitrectomy
sulfur hexafluoride (SF6)
5/8-in 25-gauge needle
laser
Sponsored by
Sunnybrook Health Sciences Centre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rhegmatogenous Retinal Detachment focused on measuring Corneal Endothelial Cell Loss, pneumatic retinopexy, vitrectomy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Sites / Locations

  • Sunnybrook Health Sciences Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

pneumatic retinopexy group

vitrectomy group

Arm Description

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 The total volume of gas injected will exceed by 0.3 ml the amount of fluid withdrawn by the anterior chamber paracentesis (ex: 0.6 ml of SF6 would be injected after having withdrawn 0.3 ml).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.

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

Outcomes

Primary Outcome Measures

Endothelial cells count as measured by specular microscopy

Secondary Outcome Measures

Full Information

First Posted
June 9, 2014
Last Updated
July 8, 2014
Sponsor
Sunnybrook Health Sciences Centre
search

1. Study Identification

Unique Protocol Identification Number
NCT02185469
Brief Title
Corneal Endothelial Cell Loss After Pneumatic Retinopexy for the Repair of Primary Rhegmatogenous Retinal Detachment
Official Title
Corneal Endothelial Cell Loss After Pneumatic Retinopexy for the Repair of Primary Rhegmatogenous Retinal Detachment
Study Type
Interventional

2. Study Status

Record Verification Date
July 2014
Overall Recruitment Status
Unknown status
Study Start Date
July 2014 (undefined)
Primary Completion Date
June 2015 (Anticipated)
Study Completion Date
July 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sunnybrook Health Sciences Centre

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rhegmatogenous Retinal Detachment
Keywords
Corneal Endothelial Cell Loss, pneumatic retinopexy, vitrectomy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
pneumatic retinopexy group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
vitrectomy group
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Procedure
Intervention Name(s)
Pneumatic retinopexy
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
vitrectomy
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
sulfur hexafluoride (SF6)
Intervention Type
Device
Intervention Name(s)
5/8-in 25-gauge needle
Intervention Type
Device
Intervention Name(s)
laser
Intervention Description
intraoperative laser retinopexy
Primary Outcome Measure Information:
Title
Endothelial cells count as measured by specular microscopy
Time Frame
at 3 and 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Charlene Muller, RN, PHN,CCRP
Phone
416-480-5091
Email
charlene.muller@sunnybrook.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter Kertes, MD, CM, FRCSC
Organizational Affiliation
Sunnybrook Health Sciences Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sunnybrook Health Sciences Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Charlene Muller, RN, PHN,CCRP
Phone
416-480-5091
Email
charlene.muller@sunnybrook.ca
First Name & Middle Initial & Last Name & Degree
Peter Kertes, MD, CM, FRCSC

12. IPD Sharing Statement

Learn more about this trial

Corneal Endothelial Cell Loss After Pneumatic Retinopexy for the Repair of Primary Rhegmatogenous Retinal Detachment

We'll reach out to this number within 24 hrs