The primary aim of this study is to evaluate mydriasis obtained with T2380 (Fixed combination of lidocaïne, phenylephrine and tropicamide) in patients with small pupils
Conditions
Interventions
Product Name: Mydrane
Product Code: T2380
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Lidocaïne
CAS Number: 73-78-9
Concentration unit: % percent
Concentration type: equal
Concent
Sponsors
Laboratoires Théa
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Signed and dated informed consent • Male or female aged over 40 years old of age • Scheduled to undergo cataract surgery by phacoemulsification (Under topical anesthesia and through clear corneal incision with placement in the bag of an foldable IOL) • Dilatation of the pupil from 5mm = Pupil diameter =65 years) no F.1.3.1 Number of subjects for this age range 30
Exclusion criteria
Exclusion criteria: Ophthalmic exclusion criteria • Surgical conditions in the eye to be operated: - Combined surgery - Previous intraocular surgery • Non-surgical conditions in the eye to be operated: - Iatrogenic or traumatic or congenital cataract. - Deformed pupil and /or iris synechiae - Very dark iris impeding slit lamp or video measures of pupil dilatation - Eye movement disorder (Nystagmus,..) - Dacryocystitis and all others pathologies of tears drainage system - History of Inflammatory ocular disease (uveitis, herpetic keratitis,…) - Corneal, epithelial, stromal or endothelial, residual or evolutionary disease (including corneal ulceration and superficial punctuate keratitis) - History of ocular traumatism, infection or inflammation within the last 3 months • Ophthalmic conditions in the contra lateral eye: - Best corrected visual acuity < 1/10 - Patient already included in the study for phakoexeresis - History of ophthalmic surgical complication Other exclusion criteria are defined in this protocol (Systemic/non ophthalmic exclusion criteria, Specific exclusion criteria for women, Exclusion criteria related to general conditions, Exclusion criteria related to concomitant medications).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary aim of this study is to evaluate mydriasis obtained with T2380 on patients with small pupils. The primary efficacy variable is the ability of the surgeon to perform a circumlinear capsulorhexis with a stable pupil size of at least 5 mm without using any other method to dilate the pupil.;Secondary Objective: The secondary efficacy variables are: • Pupil size measured at the times T1, T2, T3, T4 and T5 • Total surgical time (first incision to IOL implantation) • Assessment of patient’s discomfort at T1 to T5 • Assessment of the surgeon satisfaction of each stage (2nd incision, capsulorhexis, phacoemulsification, cortex aspiration, IOL implantation). ;Primary end point(s): The primary efficacy variable is the ability of the surgeon to perform a circumlinear capsulorhexis with a stable pupil size of at least 5 mm without using any other method to dilate the pupil. ;Timepoint(s) of evaluation of this end point: In order to realise the measurement of pupil size at specific times, surgery will be divided into 5 time periods according to the scheme mentioned in the protocol. Nota Pupil size measurement: The exact pupil size during surgery will be obtained following the formula: Pupil size = photo pupil size X corrective factor* (*) corrective factor = real HVID / photo HVID with HVID = Horizontal Visible Iris Diameter (i.e. horizontal white to white). Real HVID will be measured using IOL master during the selection visit. Photo HVID will be measured on each photo taken at 5 stages during the surgery. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Principal secondary end point of surgery will be T1, T2, T4 and T5 ;Timepoint(s) of evaluation of this end point: The pupil size will be measured on photos taken from surgery video recordings at the 5 times of surgery: • Just before the first incision (T1) • Just before OVD injection (T2) • Just before capsulorhexis (T3) • Just before IOL injection (T4) • Just after IOL implantation (T5) | — |
Countries
France
Contacts
Public ContactSandrine GUYON
Laboratoires Théa
Outcome results
None listed