Cataract surgery MedDRA version: 16.0 Level: LLT Classification code 10039960 Term: Senile cataract System Organ Class: 100000004853 MedDRA version: 16.0 Level: PT Classification code 10063797 Term: Cataract operation System Organ Class: 10042613 - Surgical and medical procedures
Conditions
Interventions
Trade Name: Mydriasert
Product Name: Mydriasert
Pharmaceutical Form: Ophthalmic insert
INN or Proposed INN: Tropicamide
CAS Number: 1508-75-4
Other descriptive name: TROPICAMIDE
Concentration unit: mg
Sponsors
Laura Sararols Ramsay
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Men and women aged from 45 to 85 years old 2. Scheduled to undergo unilateral catarcat surgery. Diagnosis of senil cataract solved by phacoemulsification + intraocular lens implant. 3. Patients who understand and sign informed consent. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 33 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 65
Exclusion criteria
Exclusion criteria: Ophthalmic conditions (elegible eye): 1.Combined surgery 2. Pupillary abnormalities (irregular,..) 3. Very dark iris 4. Iris synechiae 5. Eye movement disorder (Nystagmus,..) 6. Dacryocystitis and all others pathologies of tears drainage system 7. History of Inflammatory ocular disease (Iritis, uveitis, herpetic keratitis,….) 8. Corneal, epithelial, stromal or endothelial, residual or evolutionary disease (including corneal ulceration and superficial punctuate keratitis) 9. Pseudoexfoliation, exfoliative syndrome 10. History of ocular traumatism, infection or inflammation within the last 3 months 11. History of uveitis 12 Macular thickness >320 micrometers 13. History of any other co-existent pathology afecting visual acuity or macular thickness (corneal opacity, AMD, glaucoma, ocular hypertension,...) Ophthalmic conditions (fellow eye): 14. Best corrected visual acuity = +1,0 LogMar ó = 35 letters EDTRS or = 20/200 Snellen or = 0,1 15. Patient already included in the study for phakoexeresis 16. History of surgical complication (cystoid macular oedema...) Ocular and systemic treatments: 17. Patients under systemic treatment with mydriatic and/or miotic activity in the last 3 months before the surgery: alpha-adrenergic receptor antagonist, anticholinergic, antipsychotic medication... 18. Patients under systemic treatment with corticosteroids or immunosupressive medication in the last 3 months before the surgery 19. Patients under systemic treatments with opioids, morphinic medication, MAO inhibitors and/or tricyclic antidepressants in the last 15 days before the surgery 20. Patients using topic treatments with mydriatic and/or analgesic activity in the last 15 days before the surgery 21. Patients under any other systemic analgesic treatment in the last 7 days before the surgery (except paracetamol) 22. Contact lens wearers in the last 7 days before the surgery 23. Patients using topic antiinflamatory and antibiotic treatments the day before the surgery 24. All the treatments previously mentioned are also forbidden during the follow-up period of the study 25. Patients foreseen a change in the not forbidden systemic medication after screening visit Systemic / non ophthalmic conditions: 26. Diabetes not controlled, 27. Insulin-dependent diabetes 28. Any other medical or surgical history, disorder or disease such as acute or chronic severe organic disease: hepatic, endocrine neoplasic, haematological diseases, severe psychiatric illness, relevant cardiovascular abnormalities (such as unstable angina, uncontrolled arterial hypertension etc...) and/or any complicating factor or structural abnormality judged by the investigator to be incompatible with the study. 29. Allergic history. Known hypersensitivity to one of the components of the study medications or to test products. 30. Allergic rhinitis. 31. Pregnancy, lactation. 32. Women without an effective method of contraception (oral contraceptive, intra-uterine device, subcutaneous contraceptive implant) OR Women not hysterectomised, menopaused or surgically sterilized. Non-inclusion criteria related to general conditions: 33. Drugs comsumption 34. Participation in another clinical study in last 30 days 35. Inability of patient and/or relatives to understand the study procedures, and thus inability to give informed consent 36. Non compliant patients and/or relatives (e.g. not willing to attend the follow-up visits, way of life interfering with compli
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): Primary end point is evaluate the mydriasis at capsulorrhexis (limiting procedure during cataract surgery). Mydriasert will be efficient if just before the capsulorrhexis pupil diameter is equal or higher than 6.5 mm. Also stability of the mydriasis will be evaluated from t30 to t90 and during full surgery time. Mydriasis obtained with topical treatment will be compared with mydriasis obtained using Mydriasert and it will be asessed if mydriasis obtained in both cases is continous in the time, especially during surgery time: this could facilitate a more confortable surgery filed for the investigator. Surgery will be divided in 5 different times for measuring pupil dilatation: T1: before 1st incision T2: before the use of viscoelastic T3: before the capsulorrherxis T4: after the phacoemulsification T5: after intraocular lens implant ;Timepoint(s) of evaluation of this end point: Primary end point will be evaluated at inclusion visit, surgery visit or D0;Main Objective: -Determine pupilar diameter induced by Mydriasert at capsulorrhexis (equal or higher than 6.5 mm). -Determine pupil diameter and mydrisis stability induced by Mydriasert at t30, t45, t60 and t90 after the use of the ocular insert in the eye of the patient. Determine if Mydriasert is able to induce a mydriasis equal or higher than the topical treatment used as comparator. Measurement of mydriasis stability also will be determined not only at previously mentioned times but also during surgery time: surgery has been divided in 5 times when investigator must measure pupilar dilatation.;Secondary Objective: -Determine if there is a relationship between the use of Mydriasert for pupil dilatation and presence of macular oedema. Identify the number of cases of macular oedema at each group of treatment, the macular thickness and stability of the dilatation for each patient. Investigator will perform the measurements during the surgery at 5 different times. -Determine systemic and local tol | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): -Systemic tolerability of the IMP: determine cardiovascular parameters before, during and after surgery. -Local tolerability of the IMP: determine ocular symptoms. Patients should describe symptoms associated to Mydriasert (placing, maintenance and removal of the insert). During the long of the study investigator will evaluate ocular signs and symptoms. -Local and systemic safety: adverse events will be monitored. Local adverse event related with macular oedema will be especially monitored -Investigator assessment related to efficiency and satisfaction -Suitability of Mydriasert by the nurse assessment;Timepoint(s) of evaluation of this end point: -Local tolerability will be evaluated at D0, surgery visit or inclusion visit. Also at D1, D14, D30 and D90 -Local and systemic safety will be evaluated at D0, D1, D14, D30 and D90. Macular thickness measurement will be done at D1, D30 and D90 -Investigator assessment will be evaluated at D0 -Suitability of Mydriasert will be evaluated at D0 | — |
Countries
Spain
Contacts
Public ContactRoger Herrero
Hospital General de Catalunya
Outcome results
None listed