Latanoprost and Dorzolamide for the Treatment of Pediatric Glaucoma: The Glaucoma Italian Pediatric Study (Gipsy), Design and Baseline Characteristics.
To investigate the efficacy of a treatment strategy with latanoprost and dorzolamide in primary pediatric glaucoma patients partially responsive to surgery.



Single arm, prospective, interventional multicenter study. Primary pediatric glaucoma patients younger than 13 years after a single surgical procedure with IOP between 22 and 26 mmHg were considered eligible. At baseline, patients were allocated to latanoprost monotherapy once daily. Depending on intraocular pressure (IOP) reduction at first visit, the patients were allocated to one of three groups: continuation of latanoprost monotherapy, addition of dorzolamide twice daily, or switch to dorzolamide three times daily. The same approach for allocation in medication groups was used in all subsequent visits. Patients in the dorzolamide monotherapy group with IOP reduction <20% from baseline were considered non-responders and withdrawn. Study treatment and patient follow-up will continue for 3 years or until treatment failure. The primary endpoint is the percentage of responders. Secondary endpoints are time to treatment failure and frequency of adverse events.



A total of 37 patients (69 eyes) were enrolled. The mean age was 4.0 ± 3.8 years, the female/male ratio was 1/1.7, and the majority of patients were Caucasian. Eighty percent of patients had bilateral glaucoma. Goniotomy was the most frequently performed surgery (38.6%), followed by trabeculotomy (22.8%), trabeculectomy (21.1%), and trabeculectomy plus trabeculotomy (17.5%). The baseline IOP was 23.6 ± 1.5 mmHg.



The study population is representative of patients frequently encountered after the first surgery for primary pediatric glaucoma. The study will produce evidence on the medium-term efficacy of a defined pharmacological approach.
Department of Medical and Surgical Specialties Section of Ophthalmology, University of Brescia, Brescia, Italy.
Luciano
L
Quaranta
Laboratory of Methodology for Clinical Research, IRCCS - Istituto di Ricerche Farmacologiche Mario Negri, Milan, Italy. elena.biagioli@marionegri.it.
Elena
E
Biagioli
Laboratory of Methodology for Clinical Research, IRCCS - Istituto di Ricerche Farmacologiche Mario Negri, Milan, Italy.
Francesca
F
Galli
Laboratory of Methodology for Clinical Research, IRCCS - Istituto di Ricerche Farmacologiche Mario Negri, Milan, Italy.
Davide
D
Poli
Laboratory of Methodology for Clinical Research, IRCCS - Istituto di Ricerche Farmacologiche Mario Negri, Milan, Italy.
Eliana
E
Rulli
Department of Medical and Surgical Specialties Section of Ophthalmology, University of Brescia, Brescia, Italy.
Ivano
I
Riva
Laboratory of Methodology for Clinical Research, IRCCS - Istituto di Ricerche Farmacologiche Mario Negri, Milan, Italy.
Lital
L
Hollander
Department of Ophthalmology, University of Ioannina, Ioannina, Greece.
Andreas
A
Katsanos
Azienda Ospedaliera Universitaria, "Policlinico Vittorio Emanuele", P.O. Gaspare Rodolico, Catania, Italy.
Antonio
A
Longo
Azienda Ospedaliera Universitaria, "Policlinico Vittorio Emanuele", P.O. Gaspare Rodolico, Catania, Italy.
Maurizio G
MG
Uva
Laboratory of Methodology for Clinical Research, IRCCS - Istituto di Ricerche Farmacologiche Mario Negri, Milan, Italy.
Valter
V
Torri
Department of Ophthalmology, Shiley Eye Institute, Hamilton Glaucoma Center, University of California San Diego, San Diego, CA, USA.
Robert N
RN
Weinreb
D000959:Antihypertensive Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D002648:Child; D002675:Child, Preschool; D004359:Drug Therapy, Combination; D005260:Female; D005901:Glaucoma / Q000188:drug therapy* / Q000601:surgery; D006801:Humans; D007223:Infant; D007429:Intraocular Pressure; D007558:Italy; D000077338:Latanoprost; D008297:Male; D011446:Prospective Studies; D011461:Prostaglandins F, Synthetic / Q000008:administration & dosage; D013449:Sulfonamides / Q000008:administration & dosage / Q000627:therapeutic use*; D013876:Thiophenes / Q000008:administration & dosage / Q000627:therapeutic use*; D016896:Treatment Outcome
D000959:Antihypertensive Agents; D011461:Prostaglandins F, Synthetic; D013449:Sulfonamides; D013876:Thiophenes; D000077338:Latanoprost; C062765:dorzolamide
Dorzolamide; Latanoprost; Medical therapy; Ophthalmology; Pediatric glaucoma; Surgery