Efficacy and safety of intracameral administration of a fixed combination of mydriatics and anesthetics immediately after the first incision during cataract surgery

Session Details

Session Title: Cataract Surgery Complications Management. OVDs, Cataract Surgery Equipment

Session Date/Time: Monday 07/09/2015 | 08:00-10:00

Paper Time: 08:12

Venue: Main Auditorium

First Author: : M.Labetoulle FRANCE

Co Author(s): :    A. Behndig   B. Cochener   M. Tassignon   J. Colin           

Abstract Details

Purpose:

To compare the efficacy and safety of intracameral (IC) administration, just after the first incision during cataract surgery, of T2380, the first standardised ophthalmic combination of tropicamide 0.02%, phenylephrine 0.31% and lidocaine 1%, to a standard topical regimen.

Setting:

Multiple international centres and hospitals. Umea University Hospital, Umea, Sweden University Hospital of Brest, France University Hospital Antwerp, Antwerp, Belgium University Hospital Pellegrin, Bordeaux, France

Methods:

This phase III, prospective, randomised, controlled study in 2 parallel-groups enrolled patients undergoing phacoemulsification with intraocular lens (IOL) implantation under topical anaesthesia (2 tetracaine instillations). The selected eye of 555 patients received either IC injection of 200 μL of T2380 (T2380 Group) just after incision during cataract surgery, or a standard topical regimen of 1 drop each, of tropicamide 0.5% and phenylephrine 10% (Reference Group) repeated 3 times at 10 minute intervals, beginning 30 minutes preoperatively. The non-inferiority of T2380 to the standard topical regimen was tested. Main outcome measures were pupil size, intraoperative ocular discomfort, and safety.

Results:

Capsulorhexis was successfully performed without any other mydriatic treatment for 98.9% of patients in the T2380 Group and 94.7% in the Reference Group. The mean pupil size in the T2380 Group remained stable at 7.5 mm throughout surgery. Patients in the T2380 Group reported statistically significantly less discomfort than the Reference Group (p=0.034) during the most active phase of intraocular maneuvers. IOL insertion was classified as routine (i.e., “not technically challenging”) in a statistically greater number of eyes in the T2380 Group (96.6%) versus the Reference Group (92.9%) (p=0.047). Cardiovascular and other safety data were similar between Groups.

Conclusions:

Rapid, stable and adequate mydriasis was triggered by T2380. T2380 is an effective and safe alternative to standard mydriatic eyedrops for initiating and maintaining intraoperative mydriasis. Patients who received IC T2380 were significantly more comfortable during the active intraocular phase of the surgery and spent less overall time in the surgical center compared to patients who received a topical regimen. Surgeons found the IOL insertion less technically challenging with IC T2380.

Financial Interest:

One of the authors receives consulting fees, retainer, or contract payments from a company producing, developing or supplying the product or procedure presented