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UnknownNCT02185469

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

Status
Unknown
Phase
N/A
Study type
Interventional
Enrollment
30 (estimated)
Sponsor
Sunnybrook Health Sciences Centre · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
PROCEDUREPneumatic 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.
PROCEDUREvitrectomyUnder 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
DRUGsulfur hexafluoride (SF6)
DEVICE5/8-in 25-gauge needle
DEVICElaserintraoperative laser retinopexy

Timeline

Start date
2014-07-01
Primary completion
2015-06-01
Completion
2015-07-01
First posted
2014-07-09
Last updated
2014-07-09

Locations

1 site across 1 country: Canada

Source: ClinicalTrials.gov record NCT02185469. Inclusion in this directory is not an endorsement.