Gloria Roberti1, Luca Agnifili2, Francesca Berardo1, Ivano Riva1, Michele Figus3, Gianluca Manni1,4, Luciano Quaranta5, Francesco Oddone6. 1. Glaucoma Unit, IRCCS Fondazione G.B. Bietti, Via Livenza 3, 00198, Rome, Italy. 2. Ophthalmology Clinic, Department of Medicine and Aging Science, University G. D'Annunzio of Chieti-Pescara, Via dei Vestini 31, 66100, Chieti, Italy. 3. Department of Surgical, Medical, and Molecular Pathology and Critical Care, University of Pisa, Via Paradisa 2, Pisa, Italy. 4. DSCMT, University of Rome Tor Vergata, Viale Oxford 81, 00133, Rome, Italy. 5. Section of Ophthalmology, Department of Medical and Surgical Specialties, Radiological Sciences, and Public Health University of Brescia, Viale Europa 11, 25123, Brescia, Italy. 6. Glaucoma Unit, IRCCS Fondazione G.B. Bietti, Via Livenza 3, 00198, Rome, Italy. odd1fr@gmail.com.
Abstract
INTRODUCTION: To compare the effects of a preservative-free (PF) ophthalmic solution containing hyaluronic acid (HA) 0.4% and taurine (TAU) 0.5% with those of a PF ophthalmic solution containing HA 0.2% on ocular surface signs, symptoms, and morphological parameters in glaucoma patients under multiple long-term topical hypotensive therapy. METHODS: Eligible patients underwent evaluation of ocular surface parameters by ocular surface disease index (OSDI) and glaucoma symptom scale (GSS) questionnaires, breakup time test (BUT), Schirmer I test, corneal and conjunctival staining (Oxford scale), and conjunctival in vivo confocal microscopy (Heidelberg Retina Tomograph 3, Heidelberg Engineering GmbH, Heidelberg, Germany). After the baseline visit, patients were randomized to use a PF ophthalmic solution containing HA 0.4% and TAU 0.5%, QID, in both eyes (group 1) or to use a PF ophthalmic solution containing HA 0.2%, QID (group 2) in addition to the ongoing preserved hypotensive treatment. Follow-up visits were scheduled at 30 and 90 days. RESULTS:Thirty-nine eyes of 39 glaucoma patients were included in the study. At baseline, results of study tests of both groups were similar. After 90 days in group 1 the BUT (p = 0.01), the Oxford score (p = 0.03), the conjunctival goblet cells (CGC) density (p = 0.0005) ,and the two questionnaires score significantly improved (OSDI, p = 0.003; GSS, p = 0.003) compared to baseline values, while in group 2 all these parameters did not differ from baseline (BUT, p = 0.39; Oxford score, p = 0.54; CGC density, p = 0.33, OSDI p = 0.65, GSS, p = 0.25). The BUT and the CGC density were statistically different between groups both at 30 and 90 days (p = 0.04 and p = 0.04, respectively). The Schirmer I test did not statistically change after 90 days in both groups. CONCLUSIONS: The PF ophthalmic solution with HA 0.4% and TAU 0.5% seems to improve CGC density and reduce signs and symptoms of dry eye in glaucoma patients under long-term multiple preserved hypotensive therapy. TRIAL REGISTRATION: ClinicalTrials.gov identifier, NCT03480295.
RCT Entities:
INTRODUCTION: To compare the effects of a preservative-free (PF) ophthalmic solution containing hyaluronic acid (HA) 0.4% and taurine (TAU) 0.5% with those of a PF ophthalmic solution containing HA 0.2% on ocular surface signs, symptoms, and morphological parameters in glaucomapatients under multiple long-term topical hypotensive therapy. METHODS: Eligible patients underwent evaluation of ocular surface parameters by ocular surface disease index (OSDI) and glaucoma symptom scale (GSS) questionnaires, breakup time test (BUT), Schirmer I test, corneal and conjunctival staining (Oxford scale), and conjunctival in vivo confocal microscopy (Heidelberg Retina Tomograph 3, Heidelberg Engineering GmbH, Heidelberg, Germany). After the baseline visit, patients were randomized to use a PF ophthalmic solution containing HA 0.4% and TAU 0.5%, QID, in both eyes (group 1) or to use a PF ophthalmic solution containing HA 0.2%, QID (group 2) in addition to the ongoing preserved hypotensive treatment. Follow-up visits were scheduled at 30 and 90 days. RESULTS: Thirty-nine eyes of 39 glaucomapatients were included in the study. At baseline, results of study tests of both groups were similar. After 90 days in group 1 the BUT (p = 0.01), the Oxford score (p = 0.03), the conjunctival goblet cells (CGC) density (p = 0.0005) ,and the two questionnaires score significantly improved (OSDI, p = 0.003; GSS, p = 0.003) compared to baseline values, while in group 2 all these parameters did not differ from baseline (BUT, p = 0.39; Oxford score, p = 0.54; CGC density, p = 0.33, OSDI p = 0.65, GSS, p = 0.25). The BUT and the CGC density were statistically different between groups both at 30 and 90 days (p = 0.04 and p = 0.04, respectively). The Schirmer I test did not statistically change after 90 days in both groups. CONCLUSIONS: The PF ophthalmic solution with HA 0.4% and TAU 0.5% seems to improve CGC density and reduce signs and symptoms of dry eye in glaucomapatients under long-term multiple preserved hypotensive therapy. TRIAL REGISTRATION: ClinicalTrials.gov identifier, NCT03480295.
Entities:
Keywords:
Conjunctival goblet cells; Glaucoma; Hyaluronic acid; In vivo confocal microscopy; Ophthalmology; Taurine
Authors: Jose Maria Martinez-de-la-Casa; Carlos Oribio-Quinto; Almudena Milans-Del-Bosch; Pilar Perez-Garcia; Laura Morales-Fernandez; Javier Garcia-Bella; Jose Manuel Benitez-Del-Castillo; Julian Garcia-Feijoo; David P Piñero Journal: Eye Vis (Lond) Date: 2022-04-01