MYDRANE (tropicamide, phenylephrine, lidocaine), mydriatic and anaesthetic

OPHTHALMOLOGY - New medicinal product
Opinions on drugs - Posted on Nov 10 2016

Reason for request

Inclusion

No clinical benefit demonstrated in obtaining mydriasis in cataract surgery when compared with other mydriatics.

  • MYDRANE has Marketing Authorisation in cataract surgery for obtaining mydriasis and intraocular anaesthesia during the surgical procedure in adults.
  • The intracameral route makes it fast-acting and eliminates the preoperative dilation phase, which enables the overall patient care time to be reduced, though not the surgery time.
  • Its non-inferiority has been demonstrated compared to a standard pupil dilation protocol, that includes instillation of mydriatics in the form of eyedrops, in terms of obtaining sufficient mydriasis when performing capsulorhexis without any additional mydriatic treatment.

 

 


Clinical Benefit

Substantial

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Clinical Added Value

no clinical added value

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Therapeutic use

-

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