Status:
COMPLETED
Efficacy and Safety of Topically Applied Medical Therapy for the Treatment of Pediatric Glaucoma
Lead Sponsor:
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
Conditions:
Childhood Glaucoma
Eligibility:
All Genders
1-12 years
Phase:
PHASE2
Brief Summary
Objectives: The study will assess the ocular hypotensive effect of latanoprost and dorzolamide in a selected sample of patients affected by primary Pediatric Glaucoma (PG), refractory to surgical pro...
Detailed Description
Study design: Single arm, prospective, experimental study. Due to ethical reasons and in order to adhere as much as possible to current clinical practice, the presence of a control arm is not planned...
Eligibility Criteria
Inclusion
- Children of either sexes, aged 0-12 years
- Diagnosis of mono- or bilateral primary congenital glaucoma
- IOP greater than or equal to 22 mmHg and lower than 27 mmHg
- Only one previous ocular hypotensive surgical procedure for treatment of glaucoma among the following: goniotomy, trabeculotomy, trabeculotomy with adjunct of mitomycin C) (only for medical treatment at least one month before)
- Parent informed consent to data processing (at registration)
- Parent informed consent before any study procedure
Exclusion
- Secondary glaucoma (Sturge-Weber syndrome, type I neurofibromatosis, retinoblastoma, steroid-induced glaucoma, etc.)
- Presence of concomitant abnormalities of the anterior segment of the eye (cataract, iridocorneal dysgenesia, congenital uveal ectropion uvea, etc.)
- Previous treatment with the study drugs
- Presence of concomitant systemic diseases (asthma, hypertension, cardiac disease, renal failure, etc.) that needs treatment with drugs, that could influence IOP (steroids, beta-blockers, angiotensin-converting-enzyme inhibitor -inhibitors diuretics, etc.)
- Abnormalities of the cornea that could influence IOP readings (marked cornea edema)
Key Trial Info
Start Date :
July 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2016
Estimated Enrollment :
37 Patients enrolled
Trial Details
Trial ID
NCT01527682
Start Date
July 1 2009
End Date
November 1 2016
Last Update
September 27 2019
Active Locations (2)
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1
Azienda Ospedaliera Spedali Civili di Brescia
Brescia, Italy, 25123
2
A.O. Universitaria " Policlinico Vittorio Emanuele" P.O. Rodolico
Catania, Italy, 95123