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Papers by Maurizio Rolando

Research paper thumbnail of Improvement of post-cataract dry eye by 0.05% cyanocobalamine plus 0.5% taurine and 0.5% long-chained hyaluronic acid

Investigative Ophthalmology & Visual Science, 2013

Research paper thumbnail of Reduction of Evaporative Tear Water Loss from the Ocular Surface by Means of a Lipid Containing Tear Substitute

Investigative Ophthalmology & Visual Science, May 1, 2004

Research paper thumbnail of Assessment of the efficacy of Cationorm® in patients with moderate dry eye compared with Optive® and Emustil® eye drops

Acta Ophthalmologica, Sep 1, 2011

Purpose Dry eye disease (DED), the result of an insufficient tear film, is manifest by symptoms o... more Purpose Dry eye disease (DED), the result of an insufficient tear film, is manifest by symptoms of ocular discomfort and ocular surface damage. An ideal DED therapy would regenerate each deficient tear film layer. Cationorm®, a preservative‐free cationic emulsion, augments the aqueous‐mucous and lipid layers of the tear film and reduces evaporation. The efficacy of Cationorm® was evaluated.Methods Adults with moderate DED defined by at least 1 symptom >3 cm on a visual analog scale (VAS) and total corneal fluorescein score ≥3 and tear film break up time (BUT) <7 seconds were enrolled in a 3 month, controlled, randomized, single‐masked study. Randomization to qid treatment with Cationorm® (Novagali), Optive® (Allergan) or Emustil® (SIFI) followed a washout period. Efficacy assessments were evaluated at 1 and 3 months.Results Of 71 patients, 8 (44%) Emustil treated patients discontinued prior to month 3. At month 1, the VAS score in Optive® and Cationorm® patients revealed a statistically significant improvement evident by month 3 for all treatments. Improvements in BUT and reduced fluorescein staining at month 3 were statistically significant for Cationorm® and Optive® but not Emustil®. While Cationorm® and Optive® significantly reduced tear film osmolarity only Cationorm® showed a statistically significant difference compared to Emustil®.Conclusion In moderate DED patients, Cationorm® was more effective than Emustil®. Although not statistically different, overall improvements were greater in patients treated with Cationorm® than Optive®.

Research paper thumbnail of Safety Profile of a New Tear Substitute Containing Hyaluronic Acid and a Low Dose of Hydrocortisone

Investigative Ophthalmology & Visual Science, Jun 10, 2020

Research paper thumbnail of The Effect of Tapered Small Dose Steroidal Treatment on Symptoms, Clinical Signs, and Ocular Surface Inflammation in Patients with Dry Eye Syndrome

Investigative Ophthalmology & Visual Science, 2011

Research paper thumbnail of Ocular Surface Changes in Patients With Cicatricial Pemphigoid

Investigative Ophthalmology & Visual Science, 2008

Research paper thumbnail of Stadiazione del danno glaucoma

Research paper thumbnail of Possible Strategies to Mitigate Placebo or Vehicle Response in Dry Eye Disease Trials: A Narrative Review

Ophthalmology and Therapy

Many candidate drugs for dry eye disease (DED) have been assessed over the years in pursuit of de... more Many candidate drugs for dry eye disease (DED) have been assessed over the years in pursuit of demonstrating efficacy in both signs and symptoms. However, patients with DED have very limited treatment options for management of both signs and symptoms of DED. There are several potential reasons behind this including the placebo or vehicle response, which is a frequent issue observed in DED trials. A high magnitude of vehicle response interferes with the estimation of a drug's treatment effect and may lead to failure of a clinical trial. To address these concerns, Tear Film and Ocular Surface Society International Dry Eye Workshop II taskforce has recommended a few study design strategies to minimize vehicle response observed in DED trials. This review briefly describes the factors that lead to placebo/vehicle response in DED trials and focuses on the aspects of clinical trial design that can be improved to mitigate vehicle response. In addition, it presents the observations from a recent ECF843 phase 2b study, wherein the study design approach consisted of a vehicle run-in phase, withdrawal phase, and masked treatment transition, and led to consistent data for DED signs and symptoms and reduced vehicle response post randomization.

Research paper thumbnail of Safety and Efficacy of Pneumatic Trabeculoplasty in African Population

Investigative Ophthalmology & Visual Science, May 1, 2006

Aim of our study was to determine the efficacy and the safety of pneumatic trabeculoplasty (PNT) ... more Aim of our study was to determine the efficacy and the safety of pneumatic trabeculoplasty (PNT) alone to lower IOP in African patients with primary open angle glaucoma (POAG). MATERIALS AND METHODS • 82 eyes of 42 patients (age > 18 years) with elevated IOP associated with a diagnosis of POAG; •IOP was evaluated with Goldmann applanation tonometry (Haag-Streit, Switzerland); •Exclusion criteria: clinically significant corneal disorders; ongoing or previous history of intraocular inflammation; any intraocular surgery; •PNT was performed on day 0 and 7 •IOP was evaluated on day 0 (before and 30 minutes after PNT), 1, 7 (before and 30 minutes after PNT), 8. •The pneumatic suction ring was centered on the clear cornea and pressed down slightly until full suction was achieved. •This pneumatic suction ring was left on the eye for 60 seconds. •It was removed for 5 minutes.

Research paper thumbnail of Efficacy of a New Tear Substitute Containing Hyaluronic Acid and a Low Dose of Hydrocortisone in Dry Eye Disease

Research paper thumbnail of 5 FU e trabeculectomia: accorgimenti per la prevenzione delle complicazioni

Research paper thumbnail of Improvement of ocular surface environment and cell conditions by means of hypotonic 0.4% hyaluronic acid tear substitute in keratoconjunctivitis sicca (KSC)

Research paper thumbnail of Variazioni del potere diottrico della superficie oculare tra due ammiccamenti indotte dal film lacrimale

Research paper thumbnail of Diagnosis and Management of Lid and Ocular Surface Disorders

... qualita-tively normal 5. Patency of and proper pressure relationships within the lacrimal dra... more ... qualita-tively normal 5. Patency of and proper pressure relationships within the lacrimal drainage pathways 5< Figure 6-1 Anatomy of the ... direct innervation of the meibomian gland acini or through the indirect regulation of the vasculature to control the synthesis and excretion of ...

Research paper thumbnail of Efficacia del piroftal nel controllo della infiammazione dopo argon laser trabeculoplastica

Research paper thumbnail of L'Esame Clinico Della Papilla e Dell'Area Peripapillare

Research paper thumbnail of Evaluation of Changes in Ocular Surface After Vitrectomy Surgery

Investigative Ophthalmology & Visual Science, Sep 26, 2016

Research paper thumbnail of The Definition and Classification of Dry Eye Disease: Report of the Definition and Classification Subcommittee of the International Dry Eye Workshop (2007)

Ocular Surface, Apr 1, 2007

The aim of the DEWS Definition and Classification Subcommittee was to provide a contemporary defi... more The aim of the DEWS Definition and Classification Subcommittee was to provide a contemporary definition of dry eye disease, supported within a comprehensive classification framework. A new definition of dry eye was developed to reflect current understanding of the disease, and the committee recommended a three-part classification system. The first part is etiopathogenic and illustrates the multiple causes of dry eye. The second is mechanistic and shows how each cause of dry eye may act through a common pathway. It is stressed that any form of dry eye can interact with and exacerbate other forms of dry eye, as part of a vicious circle. Finally, a scheme is presented, based on the severity of the dry eye disease, which is expected to provide a rational basis for therapy. These guidelines are not intended to override the clinical assessment and judgment of an expert clinician in individual cases, but they should prove helpful in the conduct of clinical practice and research.

Research paper thumbnail of Conjunctiva: Epithelial & Goblet Cell Biology

Research paper thumbnail of Association of dry eye with laryngopharyngeal reflux in clinical practice. Reply to Lechien et al

Current Eye Research, Nov 29, 2021

ABSTRACT Background Dry eye disease (DED) is a common disorder, accounting for up to 35% of the g... more ABSTRACT Background Dry eye disease (DED) is a common disorder, accounting for up to 35% of the general population. Therefore, we hypothesized that laryngopharyngeal reflux (LPR), inducing refluxate rising into airways, may involve the ocular surface and may either induce or worsen DED. Aim To investigate the prevalence and relevance of suspected LPR in DED patients and subjects with refractive problems (RP) without DED, they were defined as non-dry eye group (NEG) in clinical practice. Methods This retrospective study included consecutive patients evaluated because of dry eye-like symptoms at eight tertiary ophthalmological clinics. Parameters included reflux symptom index (RSI), ocular surface disease index (OSDI), symptom assessment in dry eye (SANDE) for frequency and severity, Schirmer test, tear break-up time (BUT), and Oxford grading. Results The study included 245 subjects (72.5% females; mean age 56.3 years), 152 DED patients, and 93 sex- and age-matched NEG subjects. Pathological RSI (score>13) was detected in 80 subjects (32.6%); 68 (85%) with DED and 12 (15%) CG (OR = 8; p < .0001). In NEG, pathological RSI was associated with higher SANDE (Frequency and Severity), OSDI, and Schirmer scores (OR = 16.36; 14.51; 12.54; and 7.22, respectively. In DED patients, pathological RSI was associated with higher OSDI values (OR = 8.75). Conclusion Patients with DED are at eight times higher risk for having pathological RSI than NEG patients. Moreover, pathological RSI was associated with more severe ocular symptoms both in DED and non-DED patients. The role of LPR in definite DED patients remains to be clarified, but this condition deserves to be investigated in managing patients with DED symptoms.

Research paper thumbnail of Improvement of post-cataract dry eye by 0.05% cyanocobalamine plus 0.5% taurine and 0.5% long-chained hyaluronic acid

Investigative Ophthalmology & Visual Science, 2013

Research paper thumbnail of Reduction of Evaporative Tear Water Loss from the Ocular Surface by Means of a Lipid Containing Tear Substitute

Investigative Ophthalmology & Visual Science, May 1, 2004

Research paper thumbnail of Assessment of the efficacy of Cationorm® in patients with moderate dry eye compared with Optive® and Emustil® eye drops

Acta Ophthalmologica, Sep 1, 2011

Purpose Dry eye disease (DED), the result of an insufficient tear film, is manifest by symptoms o... more Purpose Dry eye disease (DED), the result of an insufficient tear film, is manifest by symptoms of ocular discomfort and ocular surface damage. An ideal DED therapy would regenerate each deficient tear film layer. Cationorm®, a preservative‐free cationic emulsion, augments the aqueous‐mucous and lipid layers of the tear film and reduces evaporation. The efficacy of Cationorm® was evaluated.Methods Adults with moderate DED defined by at least 1 symptom &gt;3 cm on a visual analog scale (VAS) and total corneal fluorescein score ≥3 and tear film break up time (BUT) &lt;7 seconds were enrolled in a 3 month, controlled, randomized, single‐masked study. Randomization to qid treatment with Cationorm® (Novagali), Optive® (Allergan) or Emustil® (SIFI) followed a washout period. Efficacy assessments were evaluated at 1 and 3 months.Results Of 71 patients, 8 (44%) Emustil treated patients discontinued prior to month 3. At month 1, the VAS score in Optive® and Cationorm® patients revealed a statistically significant improvement evident by month 3 for all treatments. Improvements in BUT and reduced fluorescein staining at month 3 were statistically significant for Cationorm® and Optive® but not Emustil®. While Cationorm® and Optive® significantly reduced tear film osmolarity only Cationorm® showed a statistically significant difference compared to Emustil®.Conclusion In moderate DED patients, Cationorm® was more effective than Emustil®. Although not statistically different, overall improvements were greater in patients treated with Cationorm® than Optive®.

Research paper thumbnail of Safety Profile of a New Tear Substitute Containing Hyaluronic Acid and a Low Dose of Hydrocortisone

Investigative Ophthalmology & Visual Science, Jun 10, 2020

Research paper thumbnail of The Effect of Tapered Small Dose Steroidal Treatment on Symptoms, Clinical Signs, and Ocular Surface Inflammation in Patients with Dry Eye Syndrome

Investigative Ophthalmology & Visual Science, 2011

Research paper thumbnail of Ocular Surface Changes in Patients With Cicatricial Pemphigoid

Investigative Ophthalmology & Visual Science, 2008

Research paper thumbnail of Stadiazione del danno glaucoma

Research paper thumbnail of Possible Strategies to Mitigate Placebo or Vehicle Response in Dry Eye Disease Trials: A Narrative Review

Ophthalmology and Therapy

Many candidate drugs for dry eye disease (DED) have been assessed over the years in pursuit of de... more Many candidate drugs for dry eye disease (DED) have been assessed over the years in pursuit of demonstrating efficacy in both signs and symptoms. However, patients with DED have very limited treatment options for management of both signs and symptoms of DED. There are several potential reasons behind this including the placebo or vehicle response, which is a frequent issue observed in DED trials. A high magnitude of vehicle response interferes with the estimation of a drug's treatment effect and may lead to failure of a clinical trial. To address these concerns, Tear Film and Ocular Surface Society International Dry Eye Workshop II taskforce has recommended a few study design strategies to minimize vehicle response observed in DED trials. This review briefly describes the factors that lead to placebo/vehicle response in DED trials and focuses on the aspects of clinical trial design that can be improved to mitigate vehicle response. In addition, it presents the observations from a recent ECF843 phase 2b study, wherein the study design approach consisted of a vehicle run-in phase, withdrawal phase, and masked treatment transition, and led to consistent data for DED signs and symptoms and reduced vehicle response post randomization.

Research paper thumbnail of Safety and Efficacy of Pneumatic Trabeculoplasty in African Population

Investigative Ophthalmology & Visual Science, May 1, 2006

Aim of our study was to determine the efficacy and the safety of pneumatic trabeculoplasty (PNT) ... more Aim of our study was to determine the efficacy and the safety of pneumatic trabeculoplasty (PNT) alone to lower IOP in African patients with primary open angle glaucoma (POAG). MATERIALS AND METHODS • 82 eyes of 42 patients (age > 18 years) with elevated IOP associated with a diagnosis of POAG; •IOP was evaluated with Goldmann applanation tonometry (Haag-Streit, Switzerland); •Exclusion criteria: clinically significant corneal disorders; ongoing or previous history of intraocular inflammation; any intraocular surgery; •PNT was performed on day 0 and 7 •IOP was evaluated on day 0 (before and 30 minutes after PNT), 1, 7 (before and 30 minutes after PNT), 8. •The pneumatic suction ring was centered on the clear cornea and pressed down slightly until full suction was achieved. •This pneumatic suction ring was left on the eye for 60 seconds. •It was removed for 5 minutes.

Research paper thumbnail of Efficacy of a New Tear Substitute Containing Hyaluronic Acid and a Low Dose of Hydrocortisone in Dry Eye Disease

Research paper thumbnail of 5 FU e trabeculectomia: accorgimenti per la prevenzione delle complicazioni

Research paper thumbnail of Improvement of ocular surface environment and cell conditions by means of hypotonic 0.4% hyaluronic acid tear substitute in keratoconjunctivitis sicca (KSC)

Research paper thumbnail of Variazioni del potere diottrico della superficie oculare tra due ammiccamenti indotte dal film lacrimale

Research paper thumbnail of Diagnosis and Management of Lid and Ocular Surface Disorders

... qualita-tively normal 5. Patency of and proper pressure relationships within the lacrimal dra... more ... qualita-tively normal 5. Patency of and proper pressure relationships within the lacrimal drainage pathways 5&lt; Figure 6-1 Anatomy of the ... direct innervation of the meibomian gland acini or through the indirect regulation of the vasculature to control the synthesis and excretion of ...

Research paper thumbnail of Efficacia del piroftal nel controllo della infiammazione dopo argon laser trabeculoplastica

Research paper thumbnail of L'Esame Clinico Della Papilla e Dell'Area Peripapillare

Research paper thumbnail of Evaluation of Changes in Ocular Surface After Vitrectomy Surgery

Investigative Ophthalmology & Visual Science, Sep 26, 2016

Research paper thumbnail of The Definition and Classification of Dry Eye Disease: Report of the Definition and Classification Subcommittee of the International Dry Eye Workshop (2007)

Ocular Surface, Apr 1, 2007

The aim of the DEWS Definition and Classification Subcommittee was to provide a contemporary defi... more The aim of the DEWS Definition and Classification Subcommittee was to provide a contemporary definition of dry eye disease, supported within a comprehensive classification framework. A new definition of dry eye was developed to reflect current understanding of the disease, and the committee recommended a three-part classification system. The first part is etiopathogenic and illustrates the multiple causes of dry eye. The second is mechanistic and shows how each cause of dry eye may act through a common pathway. It is stressed that any form of dry eye can interact with and exacerbate other forms of dry eye, as part of a vicious circle. Finally, a scheme is presented, based on the severity of the dry eye disease, which is expected to provide a rational basis for therapy. These guidelines are not intended to override the clinical assessment and judgment of an expert clinician in individual cases, but they should prove helpful in the conduct of clinical practice and research.

Research paper thumbnail of Conjunctiva: Epithelial & Goblet Cell Biology

Research paper thumbnail of Association of dry eye with laryngopharyngeal reflux in clinical practice. Reply to Lechien et al

Current Eye Research, Nov 29, 2021

ABSTRACT Background Dry eye disease (DED) is a common disorder, accounting for up to 35% of the g... more ABSTRACT Background Dry eye disease (DED) is a common disorder, accounting for up to 35% of the general population. Therefore, we hypothesized that laryngopharyngeal reflux (LPR), inducing refluxate rising into airways, may involve the ocular surface and may either induce or worsen DED. Aim To investigate the prevalence and relevance of suspected LPR in DED patients and subjects with refractive problems (RP) without DED, they were defined as non-dry eye group (NEG) in clinical practice. Methods This retrospective study included consecutive patients evaluated because of dry eye-like symptoms at eight tertiary ophthalmological clinics. Parameters included reflux symptom index (RSI), ocular surface disease index (OSDI), symptom assessment in dry eye (SANDE) for frequency and severity, Schirmer test, tear break-up time (BUT), and Oxford grading. Results The study included 245 subjects (72.5% females; mean age 56.3 years), 152 DED patients, and 93 sex- and age-matched NEG subjects. Pathological RSI (score>13) was detected in 80 subjects (32.6%); 68 (85%) with DED and 12 (15%) CG (OR = 8; p < .0001). In NEG, pathological RSI was associated with higher SANDE (Frequency and Severity), OSDI, and Schirmer scores (OR = 16.36; 14.51; 12.54; and 7.22, respectively. In DED patients, pathological RSI was associated with higher OSDI values (OR = 8.75). Conclusion Patients with DED are at eight times higher risk for having pathological RSI than NEG patients. Moreover, pathological RSI was associated with more severe ocular symptoms both in DED and non-DED patients. The role of LPR in definite DED patients remains to be clarified, but this condition deserves to be investigated in managing patients with DED symptoms.