An open-label randomised clinical trial to evaluate the effects of Mydrane and standard topical mydriatics and anaesthetics protocol on ocular surface after cataract surgery

Session Details

Session Title: Cataract Surgery: Complications & Management

Session Date/Time: Tuesday 17/09/2019 | 14:00-16:00

Paper Time: 15:22

Venue: Free Paper Forum: Podium 1

First Author: : S.Souki SPAIN

Co Author(s): :    F. Manero   J. Guell                          

Abstract Details

Purpose:

Cataract surgery (CS) may induce or aggravate dry eye disease. Proper management of ocular surface pre/postoperatively can increase patient satisfaction after CS. Pupillary dilatation is commonly achieved by mydriatic/cycloplegic agents repeated administration before CS that can impact integrity of ocular surface. Intracameral (IC) route of mydriatics delivers direct to the anterior chamber the right dose of drugs to achieve pupillary dilatation and minimize adverse effects. IC administration reduces the need of preoperative eye drops, mitigating corneal toxicity and ocular surface damage. The study was designed to assess Mydrane® effect (Laboratoires Théa,France) compared to standard mydriatics eye-drops protocol on ocular surface.

Setting:

This is a phase IV, open-label, randomized clinical trial conducted in a private institution, Instituto de Microcirugía Ocular (IMO), Barcelona, Spain. All surgeries were performed by one experienced surgeon (Dr.Güell).

Methods:

50 patients, aged 40 to 88 years, undergoing cataract surgery in both eyes were included in the study. Mydrane® was administered in one eye and the standard eye-drop protocol in the fellow eye. Before performing the cataract surgery in the first eye, subjects were randomized (1:1) to receive Mydrane® (with oxybuprocain chlorhydrate 0.4%+ tetracaine chlorhydrate 0.1%) or just eye-drops (oxybuprocain chlorhydrate 0.4% + tetracaine chlorhydrate 0.1%, phenylephrine 10% and tropicamide 1%). Surgery of the fellow eye was performed within 7 days after the first surgery. Patients were evaluated before, immediately after, 1 day and 7 days after the surgery.

Results:

Ocular surface health was evaluated pre/postoperatively. Slit-lamp examination was performed to assess epithelial alterations. Photographs were taken and a blind-ophthalmologist-reader evaluated conjunctival hyperaemia graded as per MacMonnies photographic scale, corneal staining with fluorescein as per Oxford schema and conjunctival staining with lissamine green as per van Bijsterveld schema. Best corrected visual acuity was evaluated. Intraocular pressure was measured. Centre point-spread function by the objective scatter index(OSI) was registered using the Optical Quality Analysis System HD AnalyzerTM (OQAS, Visiometrics, Spain). Ocular Surface Disease Index (OSDI) and ocular symptoms/signs were recorded. Patient and surgeon satisfaction were determined by 4 grade Likert scale.

Conclusions:

The first results of the present series, after the bilateral cataract surgery, suggest that the use of Mydrane® avoids some disadvantages associated with topical regimens and entails potential benefits on the ocular surface health, such as less irritation of cornea, better tear-film quality, faster recovery of visual acuity, and increased patient comfort

Financial Disclosure:

research is funded, fully or partially, by a competing company