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1.
Clin Optom (Auckl) ; 16: 93-100, 2024.
Artigo em Inglês | MEDLINE | ID: mdl-38559802

RESUMO

Introduction: Patients expect to have excellent vision and comfort when wearing soft contact lenses. The purpose of this study was to compare the wear experiences of participants with astigmatism when wearing a daily disposable soft toric lens to an established, commonly used reusable toric lens. Methods: In this crossover study, habitual soft toric lens wearers were fit with a daily replacement soft toric lens (delefilcon A) and a reusable, 1-month replacement soft toric lens (comfilcon A) in a randomized order. After 30 days of wear, Visual analog scale (VAS) surveys were used to assess wear experience, including vision and comfort, for overall wear and end-of-day wear. Scores were compared statistically with mixed-effects linear models. Participants also responded to questions about convenience, ease of use, and satisfaction with both lenses and preference questions based upon comfort, vision, and overall performance. Results: Fifty-nine participants completed the multi-site crossover study. VAS scores [mean(std dev)] for overall quality of vision for the delefilcon A [80.4(16.4)] and comfilcon A [66.8(27.7)] lenses were statistically significant (P=0.002). The difference in the mean overall comfort scores for the delefilcon A lenses [71.6(26.3)] and comfilcon A lenses [63.2(28.9)] was 8.4, which exceeds the establish criteria for clinical significance, although not statistically significant (P=0.08). Overall satisfaction scores were 68.8(26.9) for the delefilcon A and 59.7(30.3) for the comfilcon A lenses (P=0.08). Both lenses provided mean binocular visual acuities better than 20/20 Snellen equivalent. Over half of the participants preferred the delefilcon A lenses based upon comfort, vision, and overall performance. Convenience, ease of use, and satisfaction all scored higher with delefilcon A lenses. Conclusion: The results of this study show that wear experience with delefilcon A lenses for astigmatism can meet or exceed that of comfilcon A toric lenses while also providing healthy, daily disposable lens wear.

2.
Ophthalmic Physiol Opt ; 44(4): 686-692, 2024 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-38433496

RESUMO

PURPOSE: To determine the number of previous contact lens (CL) wearers who could be comfortably refitted into delefilcon A (DAILIES TOTAL1®) CLs. METHODS: This was a 6-month, three-visit study that recruited subjects who discontinued CLs within the past 2 years because of discomfort or dryness symptoms. Subjects were required to have Standard Patient Evaluation of Eye Dryness (SPEED) questionnaire scores ≤3 and to be able to wear spherical study CLs. Subjects were asked to complete a ±50 comfort visual analogue scale (VAS) at 1 month and a Likert questionnaire after 1 and 6 months of CL wear to understand the subjects' CL experience. RESULTS: All 60 subjects who were fitted with the study CLs were still wearing them after 1 month, while one subject had dropped out by 6 months. Subjects had a median (interquartile range) age of 24.0 (7.0) years (71.7% female). They reported a median VAS score of 44.0 (8.0) units at the 1-month visit, with all reporting a comfortable score. At the 1-month/6-month visits, 98.3%/93.2%, 86.5%/78.0% and 93.2%/91.5% of subjects responded that they were very satisfied or satisfied with their vision, their end-of-day CL comfort and overall CL comfort, respectively. The same subjects responded that they were very likely or likely to continue to wear the study CLs at 1 (89.6%) and 6 months (80.7%) and to recommend the study CLs to a friend at 1 (98.3%) and 6 months (93.2%). CONCLUSIONS: The results suggest that when encountering a CL dropout, a practitioner could educate a patient about trying an alternative CL and consider delefilcon A lenses as an option.


Assuntos
Equipamentos Descartáveis , Humanos , Feminino , Masculino , Adulto , Inquéritos e Questionários , Adulto Jovem , Lentes de Contato Hidrofílicas , Satisfação do Paciente , Síndromes do Olho Seco/fisiopatologia , Pacientes Desistentes do Tratamento , Adolescente
3.
Ophthalmol Ther ; 13(2): 481-494, 2024 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-38079084

RESUMO

INTRODUCTION: The study aimed to evaluate multi-symptom relief of dry eye manifestations with the use of propylene glycol-hydroxypropyl-guar (PG-HPG) nanoemulsion lubricant eye drops, among subjects with dry eye disease (DED). METHODS: This was a post-marketing, prospective, single-arm study conducted in the USA. Subjects aged ≥ 18 years, with tear breakup time (TBUT) ≤ 10 s for both eyes, dry eye questionnaire-5 (DEQ-5) "watery eyes" symptom score 1-4, symptoms of burning/stinging, sore and tired eyes as determined by impact of dry eye on everyday living-symptom bother (IDEEL-SB) questionnaire, and IDEEL-SB score 16-65 were included. Subjects were required to complete IDEEL-SB and DEQ-5 at days 0, 14 ± 2, and 28 ± 2, and self-administer one drop of PG-HPG four times daily for 28 ± 2 days. Primary endpoints were change from baseline at day 28 in symptoms of sore, stinging/burning, and tired eyes on IDEEL-SB; and symptom of watery eyes on DEQ-5. Other endpoints evaluated were corneal staining and TBUT at baseline and day 28 ± 2; symptom relief (5-point Likert scale) at day 28 ± 2, and safety. RESULTS: Of 119 subjects enrolled, 95 completed the study (mean ± SD age 61.2 ± 13.0 years; female 69.5%). Mean IDEEL-SB scores reduced significantly from baseline at day 28 for symptoms of aching/sore eyes (change from baseline - 1.0 ± 1.1), burning/stinging eyes (change from baseline - 1.1 ± 0.9), and tired eyes (change from baseline - 1.1 ± 1.0) (all p < 0.0001). Mean DEQ-5 score for watery eye symptoms significantly reduced from baseline at day 28 (change from baseline - 0.9 ± 1.0, p < 0.0001). Corneal staining at day 28 was comparable to baseline. TBUT improved from baseline to day 28. On a Likert scale, more than 50% of subjects reported relief from symptoms of sore, stinging, and burning eyes. Three (3.1%) subjects reported treatment-emergent adverse events (non-ocular). CONCLUSIONS: PG-HPG nanoemulsion lubricant eye drops significantly improved multiple dry eye symptoms in subjects with DED over 28 days, with no new safety concerns. TRIAL REGISTRATION: ClinicalTrials.gov Identifier, NCT05056155.

4.
Clin Ophthalmol ; 16: 3631-3640, 2022.
Artigo em Inglês | MEDLINE | ID: mdl-36353670

RESUMO

Purpose: This study aimed to demonstrate the effectiveness of Systane iLux, a thermal pulsation device, in patients with MGD, over 12 months post-single treatment. Methods: This is a post-hoc analysis of a previous prospective, assessor-masked, parallel-group, multicenter study (NCT03956225) that compared the effectiveness and safety of iLux with LipiFlow in subjects with MGD. The original study included subjects with meibomian gland score (MGS) ≤12 in lower eyelids, Impact of Dry Eye on Everyday Life-Symptom Bother (IDEEL-SB) module score >16, and non-invasive tear break-up time (NITBUT) <10 seconds. Subjects were randomized (1:1) to receive a single bilateral treatment of iLux or LipiFlow. In this post-hoc analysis, mean changes in MGS, NITBUT (first break-up; seconds), IDEEL-SB module score, and corneal staining, from baseline to 12 months were analyzed post-single treatment with iLux. Results: Data from 119 patients (n=238 eyes) treated with iLux were analyzed. The mean±SD age of the subjects was 58.4±13.4 years, with majority being female (79.0%). MGS (mean±SD) for both eyes improved significantly from baseline to 12 months (OD [baseline: 6.9±3.69; month 12: 22.8±11.31; change: 15.9±11.57, p<0.0001]; OS [baseline: 6.4±3.66; month 12: 23.0±11.33; change: 16.7±11.40, p<0.0001]). Similarly, significant improvements were observed in NITBUT (OD [baseline: 5.2±1.97; month 12: 7.0±3.68; change: 1.9±3.69, p<0.0001]; OS [baseline: 5.6±1.96; month 12: 7.9±4.58; change: 2.3±4.59, p<0.0001]) and IDEEL-SB score (p<0.0001). Corneal staining reduced significantly from baseline to 12 months (OD [baseline: 2.1±2.96; month 12: 0.7±1.56; change: -1.4±2.65, p<0.0001]; OS [baseline: 2.1±2.94; month 12: 0.7±1.44; change: -1.4±2.75, p<0.0001]). Improvements in MGS, NITBUT, IDEEL-SB module score, and corneal staining were seen as early as week 2, and at months 1, 3, 6, and 9 (all p<0.001). Conclusion: A single treatment with iLux significantly improved clinical parameters of MGS, NITBUT, and corneal staining, and patient-reported symptom assessment with IDEEL-SB in patients with MGD over 12 months.

5.
Clin Ophthalmol ; 16: 2873-2884, 2022.
Artigo em Inglês | MEDLINE | ID: mdl-36065354

RESUMO

Purpose: The objective of this study was to evaluate the safety and performance of the investigational lens, lehfilcon A, when worn in a daily wear modality and replaced monthly as compared to the commercially available comfilcon A contact lens. Methods: This was a multicenter, prospective, controlled, double-masked, randomized, parallel-group clinical study with bilateral lens wear for 3 months. In all, 115 subjects completed the study (77 with test lehfilcon A and 38 with control comfilcon A contact lenses). Distance visual acuity (VA) was assessed using Snellen VA. Lens performance was assessed by examining lens fit/movement, centration, front surface wettability and front/back surface deposits using slit-lamp biomicroscopy. Results: At the 3-month follow-up visit, all eyes had a distance VA of 20/20 or better. Further, lens fit/movement was assessed as optimal in 92.9% of the eyes with lehfilcon A and 89.2% with comfilcon A. There were no ratings of unacceptably tight or loose fits for either contact lens material. Lens centration was assessed as optimal in 98.7% of eyes with lehfilcon A and 94.6% with comfilcon A. For front and back surface deposits, both materials showed minimal lens surface deposits. Front surface wettability was assessed as grade 0 or 1 for most of the study lenses in both lens groups across all attended study visits. There were no ocular adverse events related to the study lenses. Conclusion: Overall, lehfilcon A showed excellent VA, optimal lens fitting characteristics, a clean surface, high wettability, and low risk for adverse events after 3 months of lens wear.

6.
Optom Vis Sci ; 99(4): 323-332, 2022 04 01.
Artigo em Inglês | MEDLINE | ID: mdl-35383732

RESUMO

SIGNIFICANCE: Given the significance of meibomian gland dysfunction subjects in evaporative dry eye, its chronic and progressive nature, limited promising treatment options, and novel treatment techniques are important. This randomized clinical study evaluated the noninferiority of SYSTANE iLux with LipiFlow in meibomian gland dysfunction treatment at 12 months. PURPOSE: This study aimed to demonstrate noninferiority of SYSTANE iLux compared with LipiFlow at 12 months after single treatment in meibomian gland dysfunction subjects with evaporative dry eye. METHODS: In this prospective, randomized, multicenter, assessor-masked, parallel-group trial, subjects (N = 236; aged ≥18 years) with meibomian gland score (MGS) of ≤12 in lower eyelids, noninvasive tear breakup time (NITBUT; first breakup) of <10 seconds, and Impact of Dry Eye on Everyday Life-Symptom Bother (IDEEL-SB) module score of >16 were randomized (1:1) to receive SYSTANE iLux (n = 119) or LipiFlow (n = 117). Subjects attended a total of eight visits, including screening, treatment, and follow-up visits at 2 weeks and at 1, 3, 6, 9, and 12 months/exit, to evaluate change from baseline in MGS, NITBUT, IDEEL-SB module score, and safety outcomes. RESULTS: A total of 227 subjects completed the study (mean ± standard deviation age, 57.3 ± 13.8 years). At 12 months, least squares mean change from baseline in MGS was similar between iLux and LipiFlow (17.4 ± 1.97 vs. 17.8 ± 1.98). Noninferiority of SYSTANE iLux compared with LipiFlow in change from baseline in MGS (95% lower confidence limit of least squares mean difference, >-5), NITBUT (>-2.5 seconds), and IDEEL-SB score (95% upper confidence limit, <12) was achieved at all post-treatment visits. No other serious ocular or device-related adverse events were reported. CONCLUSIONS: The treatment outcomes with SYSTANE iLux were noninferior to LipiFlow during the 12-month follow-up in subjects with dry eye-associated meibomian gland dysfunction.


Assuntos
Síndromes do Olho Seco , Hipertermia Induzida , Disfunção da Glândula Tarsal , Adolescente , Adulto , Idoso , Síndromes do Olho Seco/diagnóstico , Humanos , Hipertermia Induzida/métodos , Disfunção da Glândula Tarsal/terapia , Glândulas Tarsais , Pessoa de Meia-Idade , Estudos Prospectivos , Lágrimas
7.
Optom Vis Sci ; 98(5): 483-489, 2021 05 01.
Artigo em Inglês | MEDLINE | ID: mdl-33967252

RESUMO

SIGNIFICANCE: This pilot study compared subjective and objective vision of children wearing single-vision and +2.00, +3.00, and +4.00 D add power soft multifocal contact lenses to determine whether the higher add power-thought to provide better myopia control-resulted in visual compromise. PURPOSE: This study aimed to determine the maximum add power children wearing center-distance soft multifocal contact lenses could accept objectively and subjectively. METHODS: Myopic children were assigned in random order to wear omafilcon A single-vision or multifocal "D" contact lenses with +2.00, +3.00, or +4.00 D add power for 1 week each. High-contrast distance and near visual acuity, low-contrast distance visual acuity, and contrast sensitivity were measured at each visit along with a quality of vision questionnaire to assess their vision. The Friedman test was performed to evaluate the impact of add power on all outcome measures. RESULTS: Eleven subjects were enrolled, and nine subjects completed the study. The median age of completed subjects was 11 years. Median logMAR low-contrast distance visual acuity was reduced in the +3.00 (+0.20) and +4.00 (+0.28) D add lenses compared with the +2.00 (+0.16) D add and single-vision lenses (+0.10, P < .001). All three multifocal lenses resulted in reduced contrast sensitivity (+1.35 to +1.40) compared with single-vision lenses (+1.60, P < .001). In general, +3.00 and +4.00 D add lenses resulted in worse glare/starbursts, ghost images, computer vision, changing fixation distance, and overall vision, but results varied. There were no differences among the lenses with respect to subjective assessments of distance vision, near vision, strain or tiredness, contact lens comfort, or sporting activities. CONCLUSIONS: The +3.00 D and higher add powers result in more objective and subjective vision-related issues than single-vision lenses, but the +2.00 D add multifocal lenses were well tolerated.


Assuntos
Lentes de Contato Hidrofílicas , Sensibilidades de Contraste/fisiologia , Miopia/terapia , Acuidade Visual/fisiologia , Criança , Feminino , Humanos , Masculino , Miopia/fisiopatologia , Projetos Piloto , Inquéritos e Questionários
8.
JAMA ; 324(6): 571-580, 2020 08 11.
Artigo em Inglês | MEDLINE | ID: mdl-32780139

RESUMO

Importance: Slowing myopia progression could decrease the risk of sight-threatening complications. Objective: To determine whether soft multifocal contact lenses slow myopia progression in children, and whether high add power (+2.50 D) slows myopia progression more than medium (+1.50 D) add power lenses. Design, Setting, and Participants: A double-masked randomized clinical trial that took place at 2 optometry schools located in Columbus, Ohio, and Houston, Texas. A total of 294 consecutive eligible children aged 7 to 11 years with -0.75 D to -5.00 D of spherical component myopia and less than 1.00 D astigmatism were enrolled between September 22, 2014, and June 20, 2016. Follow-up was completed June 24, 2019. Interventions: Participants were randomly assigned to wear high add power (n = 98), medium add power (n = 98), or single-vision (n = 98) contact lenses. Main Outcomes and Measures: The primary outcome was the 3-year change in cycloplegic spherical equivalent autorefraction, as measured by the mean of 10 autorefraction readings. There were 11 secondary end points, 4 of which were analyzed for this study, including 3-year eye growth. Results: Among 294 randomized participants, 292 (99%) were included in the analyses (mean [SD] age, 10.3 [1.2] years; 177 [60.2%] were female; mean [SD] spherical equivalent refractive error, -2.39 [1.00] D). Adjusted 3-year myopia progression was -0.60 D for high add power, -0.89 D for medium add power, and -1.05 D for single-vision contact lenses. The difference in progression was 0.46 D (95% CI, 0.29-0.63) for high add power vs single vision, 0.30 D (95% CI, 0.13-0.47) for high add vs medium add power, and 0.16 D (95% CI, -0.01 to 0.33) for medium add power vs single vision. Of the 4 secondary end points, there were no statistically significant differences between the groups for 3 of the end points. Adjusted mean eye growth was 0.42 mm for high add power, 0.58 mm for medium add power, and 0.66 mm for single vision. The difference in eye growth was -0.23 mm (95% CI, -0.30 to -0.17) for high add power vs single vision, -0.16 mm (95% CI, -0.23 to -0.09) for high add vs medium add power, and -0.07 mm (95% CI, -0.14 to -0.01) for medium add power vs single vision. Conclusions and Relevance: Among children with myopia, treatment with high add power multifocal contact lenses significantly reduced the rate of myopia progression over 3 years compared with medium add power multifocal and single-vision contact lenses. However, further research is needed to understand the clinical importance of the observed differences. Trial Registration: ClinicalTrials.gov Identifier: NCT02255474.


Assuntos
Lentes de Contato Hidrofílicas , Miopia/reabilitação , Criança , Lentes de Contato Hidrofílicas/efeitos adversos , Progressão da Doença , Método Duplo-Cego , Feminino , Humanos , Modelos Lineares , Masculino , Ohio , Refração Ocular , Tamanho da Amostra , Texas , Fatores de Tempo , Resultado do Tratamento
9.
Cont Lens Anterior Eye ; 42(1): 15-19, 2019 02.
Artigo em Inglês | MEDLINE | ID: mdl-30455084

RESUMO

PURPOSE: The purpose of this survey was to better understand scleral lens (SL) practitioners' fitting preferences and minor SL complications and their subsequent treatments. METHOD: Practitioners who attended the 2017 Global Specialty Lens Symposium were asked to complete an electronic questionnaire that was created by the investigators, a survey that asked practitioners about their SL fitting experience and preferences, their patients' experience with poor SL wetting, SL fogging, ocular symptoms (redness, pain/discomfort, dryness), and blurred central and side vision, and how the practitioners treated these conditions. RESULTS: This study analyzed data from 164 SL practitioners. The practitioners had been in practice for 16.3 ± 13.4 years, had been fitting SL for 5.5 ± 5.0 years, and fit 7.4 ± 7.1 SL/month. Practitioners preferred a SL with a final central corneal clearance of ∼200 µm and an overall diameter between 15.1 mm to 16.5 mm. Poor SL wetting (90.8% of practitioners documented condition), SL fogging (84.8%), blurred central vision (40.2%), ocular redness (34.8%), ocular dryness (24.4%), ocular pain/discomfort (20.7%), and blurred side vision (12.8%) were encountered by the practitioners. Practitioners preferred treating poor wetting and fogging with lens removal, cleaning, and reapplication, blurred central vision with a lens power change, blurred side (peripheral) vision, ocular redness, and ocular pain with a lens parameter change, and dryness with artificial tears. CONCLUSIONS: Most SL practitioners preferred a SL central corneal clearance of ∼200 µm, and they occasionally encountered SL-related complications in their practice, which they treated similarly to corneal gas permeable CLs.


Assuntos
Lentes de Contato Hidrofílicas/efeitos adversos , Optometristas/estatística & dados numéricos , Prática Profissional/estatística & dados numéricos , Ajuste de Prótese/tendências , Esclera , Adulto , Feminino , Pesquisas sobre Atenção à Saúde , Humanos , Masculino , Pessoa de Meia-Idade , Inquéritos e Questionários , Acuidade Visual
10.
Eye Contact Lens ; 45(1): 28-33, 2019 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-30562274

RESUMO

OBJECTIVES: To compare the effect of toric versus spherical soft contact lenses on objective measures of visual performance using visual acuity and electromyography of the orbicularis oculi muscle. METHODS: Current soft contact lens wearers with -0.75 to -1.75 D astigmatism in each eye were binocularly fitted with toric (1-Day ACUVUE MOIST for astigmatism) and spherical (1-Day ACUVUE MOIST) contact lenses in random order. After each fitting and at 1-week follow-up, high- and low-contrast visual acuities were measured. Electromyography was used to objectively evaluate eyestrain. Linear mixed models were used to assess differences between toric and spherical contact lenses. RESULTS: The mean age (±SD) of the 60 participants was 27.5±5.0 years, spherical refractive error was -3.68±2.01 D, and cylinder was -1.28±0.36 D. High- and low-contrast visual acuities with toric lenses were better than with spherical lenses at both fitting (toric high-contrast: -0.065±0.078 and low-contrast: 0.133±0.103 vs. spherical high-contrast: 0.001±0.104 and low-contrast: 0.224±0.107) and follow-up (toric high-contrast: -0.083±0.087 and low-contrast: 0.108±0.107 vs. spherical high-contrast: -0.015±0.095 and low-contrast: 0.211±0.104) (all P<0.0001). Electromyography-measured eyestrain was less with toric versus spherical contact lenses at fitting (least-square ratio of toric over spherical=0.72; P=0.0019) but not at follow-up (ratio=0.86; P=0.11). CONCLUSION: These results suggest that toric contact lenses provided improved objective measures of vision in a low-to-moderate astigmatic population.


Assuntos
Astenopia/terapia , Lentes de Contato Hidrofílicas , Músculos Oculomotores/fisiopatologia , Refração Ocular/fisiologia , Erros de Refração/terapia , Acuidade Visual , Adolescente , Adulto , Astenopia/etiologia , Astenopia/fisiopatologia , Estudos Cross-Over , Eletromiografia , Desenho de Equipamento , Feminino , Seguimentos , Humanos , Masculino , Pessoa de Meia-Idade , Erros de Refração/complicações , Erros de Refração/fisiopatologia , Estudos Retrospectivos , Método Simples-Cego , Adulto Jovem
11.
Optom Vis Sci ; 95(4): 292-298, 2018 04.
Artigo em Inglês | MEDLINE | ID: mdl-29561497

RESUMO

SIGNIFICANCE: Practitioners fitting contact lenses for myopia control frequently question whether a myopic child can achieve good vision with a high-add multifocal. We demonstrate that visual acuity is not different than spectacles with a commercially available, center-distance soft multifocal contact lens (MFCL) (Biofinity Multifocal "D"; +2.50 D add). PURPOSE: To determine the spherical over-refraction (SOR) necessary to obtain best-corrected visual acuity (BCVA) when fitting myopic children with a center-distance soft MFCL. METHODS: Children (n = 294) aged 7 to 11 years with myopia (spherical component) of -0.75 to -5.00 diopters (D) (inclusive) and 1.00 D cylinder or less (corneal plane) were fitted bilaterally with +2.50 D add Biofinity "D" MFCLs. The initial MFCL power was the spherical equivalent of a standardized subjective refraction, rounded to the nearest 0.25 D step (corneal plane). An SOR was performed monocularly (each eye) to achieve BCVA. Binocular, high-contrast logMAR acuity was measured with manifest spectacle correction and MFCLs with over-refraction. Photopic pupil size was measured with a pupilometer. RESULTS: The mean (±SD) age was 10.3 ± 1.2 years, and the mean (±SD) SOR needed to achieve BCVA was OD: -0.61 ± 0.24 D/OS: -0.58 ± 0.27 D. There was no difference in binocular high-contrast visual acuity (logMAR) between spectacles (-0.01 ± 0.06) and best-corrected MFCLs (-0.01 ± 0.07) (P = .59). The mean (±SD) photopic pupil size (5.4 ± 0.7 mm) was not correlated with best MFCL correction or the over-refraction magnitude (both P ≥ .09). CONCLUSIONS: Children achieved BCVA with +2.50 D add MFCLs that was not different than with spectacles. Children typically required an over-refraction of -0.50 to -0.75 D to achieve BCVA. With a careful over-refraction, these +2.50 D add MFCLs provide good distance acuity, making them viable candidates for myopia control.


Assuntos
Lentes de Contato Hidrofílicas , Miopia/terapia , Refração Ocular/fisiologia , Acuidade Visual/fisiologia , Criança , Método Duplo-Cego , Óculos , Feminino , Humanos , Masculino , Miopia/fisiopatologia , Ajuste de Prótese , Pupila/fisiologia , Testes Visuais
12.
Eye Contact Lens ; 44 Suppl 1: S296-S299, 2018 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-28945646

RESUMO

OBJECTIVES: To assess whether patient-reported measures are improved with soft toric contact lenses (TCLs) compared with soft spherical contact lenses (SCLs) and whether clinical time needed to fit TCL is greater than SCL. METHODS: Habitual contact lens wearers with vertexed spherical refraction +4.00 to +0.25 D or -0.50 to -9.00 D and cylinder -0.75 to -1.75 DC were randomly assigned to be binocularly fitted into a TCL or SCL, and masked to treatment assignment. Time to successful fit was recorded. After 5 days, the National Eye Institute Refractive Error Quality of Life Instrument (NEI-RQL-42) and modified Convergence Insufficiency Symptom Survey (CISS) were completed. After washout, subjects were fit into the alternative lens design (TCL or SCL). Outcomes were evaluated using linear mixed models for the time to fit and CISS score, generalized linear model for the successful fit, and Wilcoxon tests for the NEI-RQL-42. RESULTS: Sixty subjects (71.7% women, mean age [±SD] = 27.5±5.0 years) completed the study. The mean time to fit the TCL was 10.2±4.3 and 9.0±6.5 min for the SCL (least square [LS] mean difference (TCL-SCL)=1.2, P=0.22). Toric contact lens scored better than SCL in global NEI-RQL-42 score (P=0.006) and the clarity of vision (P=0.006) and satisfaction with correction subscales (P=0.006). CISS showed a 15% reduction in symptoms (LS mean difference [TCL-SCL]=-2.20, P=0.02). CONCLUSION: TCLs are a good option when trying to improve the vision of patients with low-to-moderate astigmatism given the subjective improvements in outcomes.


Assuntos
Lentes de Contato Hidrofílicas , Medidas de Resultados Relatados pelo Paciente , Ajuste de Prótese , Refração Ocular , Erros de Refração/terapia , Adolescente , Adulto , Estudos Cross-Over , Feminino , Seguimentos , Humanos , Masculino , Pessoa de Meia-Idade , Satisfação do Paciente , Desenho de Prótese , Qualidade de Vida , Erros de Refração/fisiopatologia , Acuidade Visual , Adulto Jovem
13.
Eye Contact Lens ; 38(2): 73-9, 2012 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-22157392

RESUMO

PURPOSE: The purpose of this pilot study was to evaluate the safety and efficacy of azithromycin ophthalmic solution 1% in patients with contact lens-related dry eye (CLDE). METHODS: This was a 4-week, single-center, open-label clinical trial in patients diagnosed with CLDE using the Contact Lens Dry Eye Questionnaire (CLDEQ). Fifty patients were enrolled in this study. The patients were randomized to 1 of 2 treatment groups: azithromycin ophthalmic solution administered bid on days 1 and 2 and on days 3 to 29±1 or Visine for Contacts rewetting drops administered qid on days 1 to 29±1. The patient diaries were used daily to collect data on comfortable and total contact lens wear time and ocular dryness throughout the treatment period. Tear osmolarity, fluorescein corneal staining, and visual acuity were also assessed during clinic visits. RESULTS: Fifty patients were enrolled, and 44 completed the study. One patient discontinued in the azithromycin group, and five patients discontinued in the rewetting drops group because of adverse events. A statistically significant increase in mean comfortable contact lens wear time from baseline was observed for the subjects treated with azithromycin ophthalmic solution as compared with the subjects treated with rewetting drops at week 4 (P=0.004; primary endpoint), in addition to weeks 2 and 3. The improvement in the mean comfortable wear time for the patients in the azithromycin treatment group exceeded 2 hrs throughout the treatment period (weeks 1-4). No significant differences were observed between the groups for total wear time, low contrast visual acuity, or tear osmolarity. Subject-rated ocular dryness (PM time assessments) was significantly improved from baseline in the subjects treated with azithromycin ophthalmic solution as compared with those treated with rewetting drops at weeks 2 and 3 endpoints (P=0.015 for each week). Additionally, a statistical difference was observed in favor of the azithromycin treatment group at week 2 for the subjects reclassifying as nondry eye as determined by the CLDEQ (P=0.05). CONCLUSIONS: Treatment with topical azithromycin ophthalmic solution was well tolerated and resulted in a significant improvement in comfortable contact lens wear time in the patients with CLDE.


Assuntos
Antibacterianos/administração & dosagem , Azitromicina/administração & dosagem , Lentes de Contato/efeitos adversos , Síndromes do Olho Seco/tratamento farmacológico , Soluções Oftálmicas/administração & dosagem , Administração Tópica , Adolescente , Adulto , Idoso , Antibacterianos/efeitos adversos , Azitromicina/efeitos adversos , Córnea/metabolismo , Síndromes do Olho Seco/etiologia , Síndromes do Olho Seco/fisiopatologia , Feminino , Fluoresceína/metabolismo , Humanos , Imidazóis/administração & dosagem , Masculino , Pessoa de Meia-Idade , Soluções Oftálmicas/efeitos adversos , Projetos Piloto , Lágrimas/química , Acuidade Visual/fisiologia , Adulto Jovem
14.
Eur J Echocardiogr ; 10(1): 74-81, 2009 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-18490271

RESUMO

AIMS: Left ventricular remodelling leads to functional mitral regurgitation resulting from annular dilatation, leaflet tethering, tenting, and decreased leaflet coaptation. Mitral valve annuloplasty restores valve competency, improving the patient's functional status and ventricular function. This study was designed to evaluate the mechanisms underlying mitral valve competency after the implantation of a Geoform annuloplasty ring using three-dimensional (3D) echocardiography. METHODS AND RESULTS: Seven patients (mean age of 65 years) with ischaemic mitral regurgitation underwent mitral valve annuloplasty with the Geoform ring and coronary artery bypass surgery. Pre- and post-operative 3D echocardiograms were performed. Following mitral annuloplasty, mitral regurgitation decreased from 3.4+/-0.2 to 0.9+/-0.3 (P-value<0.0001), mitral valve tenting volume from 13+/-1.7 to 3.2+/-0.3 mL (P-value<0.001), annulus area from 12.6+/-1.0 to 3.3+/-0.2 cm2 (P-value<0.0001), valve circumference from 13+/-0.5 to 7.3+/-0.3 cm (P-value<0.0001), septolateral distance from 2.1+/-0.1 to 1.4+/-0.06 cm (P-value<0.01) and intercommissural distance from 3.4+/-0.1 to 2.7+/-0.03 cm (P-value<0.03). There was significant decrease in the septolateral distance at the level of A2-P2 with respect to other regions. These geometric changes were associated with the improvement in the NYHA class from 3.1+/-0.3 to 1.3+/-0.3 (P-value<0.002). CONCLUSION: The mitral valve annuloplasty with the Geoform ring restores leaflet coaptation and eliminates mitral regurgitation by effectively modifying the mitral annular geometry.


Assuntos
Ecocardiografia Tridimensional , Implante de Prótese de Valva Cardíaca/métodos , Próteses Valvulares Cardíacas , Insuficiência da Valva Mitral/diagnóstico por imagem , Insuficiência da Valva Mitral/cirurgia , Isquemia Miocárdica/cirurgia , Idoso , Estudos de Coortes , Ponte de Artéria Coronária/métodos , Feminino , Seguimentos , Humanos , Masculino , Pessoa de Meia-Idade , Isquemia Miocárdica/diagnóstico por imagem , Cuidados Pós-Operatórios , Cuidados Pré-Operatórios/métodos , Probabilidade , Desenho de Prótese , Medição de Risco , Índice de Gravidade de Doença , Resultado do Tratamento
15.
Eur J Echocardiogr ; 9(2): 318-20, 2008 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-18490326

RESUMO

BACKGROUND: Quadricuspid aortic valve is one of the rare forms of congenital cardiac valvular disease. Its diagnosis is often missed, even with the transthoracic echocardiogram. Many of these patients progress to aortic incompetence later in life requiring surgical intervention. In addition, quadricuspid aortic valve can be associated with other congenital cardiac deformities. Hence early recognition and follow-up is critical in these patients. CASE PRESENTATION: We report a patient with quadricuspid aortic valve identified on intraoperative transesophageal 3-D echocardiography. This 66-year-old male presented with the features of congestive heart failure. The preoperative transthoracic echocardiogram (TTE) disclosed, moderately severe aortic valve insufficiency along with severe mitral and tricuspid regurgitation, but failed to reveal the quadricuspid anomaly of the aortic valve. Interestingly, this patient had undergone transthoracic echocardiography on two previous occasions during the past seven years for the evaluation of his valvular heart disease, which all failed to document this anomaly. Intraoperatively, transesophageal echocardiography (TEE) displayed an aortic valve composed of three medium and one small cusps. CONCLUSION: Our patient's case demonstrates the usefulness of transesophageal echocardiography in detection of this uncommon congenital malformation.


Assuntos
Valva Aórtica/anormalidades , Valva Aórtica/diagnóstico por imagem , Ecocardiografia Tridimensional , Idoso , Humanos , Achados Incidentais , Masculino
16.
J Cardiothorac Surg ; 2: 39, 2007 Sep 25.
Artigo em Inglês | MEDLINE | ID: mdl-17894872

RESUMO

BACKGROUND: Ischemic mitral regurgitation often complicates severe ischemic heart disease and adversely affects the prognosis in these patients. There is wide variation in the clinical spectrum of ischemic mitral regurgitation due to varying location and chronicity of ischemia and anomalies in annular and ventricular remodeling. As a result, there is lack of consensus in treating these patients. Treatment has to be individualized for each patient. Most of the available surgical options do not consistently correct this condition in all the patients. Chordal cutting is one of the newer surgical approaches in which cutting a limited number of critically positioned basal chordae have found success by relieving the leaflet tethering and thereby improving the coaptation of leaflets. Three-dimensional echocardiography is a potentially valuable tool in identifying the specific pattern of tethering and thus the suitability of this procedure in a given clinical scenario. CASE PRESENTATION: A 66-year-old man with cardiomyopathy and ischemic mitral regurgitation presented to us with the features of congestive heart failure. The three-dimensional echocardiography revealed severe mitral regurgitation associated with the tethering of the lateral (P1) and medial (P3) scallops of the posterior leaflet of the mitral valve due to secondary chordal attachments. The ejection fraction was only 15% with severe global systolic and diastolic dysfunction. Mitral regurgitation was successfully corrected with mitral annuloplasty and resection of the secondary chordae tethering the medial and lateral scallops of the posterior leaflet of the mitral valve. CONCLUSION: Cutting the second order chordae along with mitral annuloplasty could be a novel method to remedy Ischemic mitral regurgitation by relieving the tethering of the valve leaflets. The preoperative three-dimensional echocardiography should be considered in all patients with Ischemic mitral regurgitation to assess the complex three-dimensional interactions between the mitral valve apparatus and the left ventricle. This aids in timely surgical planning.


Assuntos
Cordas Tendinosas/cirurgia , Insuficiência da Valva Mitral/diagnóstico por imagem , Insuficiência da Valva Mitral/cirurgia , Isquemia Miocárdica/diagnóstico por imagem , Isquemia Miocárdica/cirurgia , Idoso , Procedimentos Cirúrgicos Cardíacos/métodos , Ecocardiografia Tridimensional , Humanos , Masculino , Valva Mitral/cirurgia , Insuficiência da Valva Mitral/complicações , Isquemia Miocárdica/etiologia
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