Comparative estudy of pupil dilatation induced by Mydriasert and an association of phenylephrine and tropicamide before cataract surgery

Phase 1

• Conditions: Cataract surgery; MedDRA version: 16.0Level: LLTClassification code 10039960Term: Senile cataractSystem Organ Class: 100000004853; MedDRA version: 16.0Level: PTClassification code 10063797Term: Cataract operationSystem Organ Class: 10042613 - Surgical and medical procedures; Therapeutic area: Diseases [C] - Eye Diseases [C11]

• Registration Number: EUCTR2013-000292-33-ES
• Lead Sponsor: aura Sararols Ramsay

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-09-16
• Last Update Posted: 5 September 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

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

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified