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1.
J Ocul Pharmacol Ther ; 27(6): 603-9, 2011 Dec.
Article in English | MEDLINE | ID: mdl-21999340

ABSTRACT

PURPOSE: To assess the reversibility of clinical benefits of cyclosporine 0.05% (Restasis(®); Allergan, Inc., Irvine, CA) therapy and the therapeutic gain after its delayed use by switching treatment modalities in patients with dry eyes who completed a 1-year course of therapy with artificial tears (Refresh Endura(®); Allergan, Inc., Irvine, CA) or cyclosporine 0.05%. METHODS: This was a single-center, prospective, investigator-masked, longitudinal extension trial. Patients who had been treated with cyclosporine 0.05% in the first year of study were randomized in a 2:1 ratio to either cyclosporine 0.05% (Cs-Cs; n=20) or artificial tears (Cs-At; n=8), and those who had been originally randomized to artificial tears were switched to cyclosporine 0.05% (At-Cs; n=20) in the second year of study. Patients received study drugs twice daily for 12 months. Disease severity was assessed according to the International Task Force consensus guideline at months 0 and 12. Signs and symptoms were evaluated at baseline (month 0) and months 4, 8, and 12. RESULTS: At baseline, most patients with Cs-Cs and Cs-At (>90%) had level 2 disease severity, whereas almost half of the patients with At-Cs had level 3 disease severity. At month 12, a significantly higher percentage of patients with Cs-Cs and At-Cs than patients with Cs-At had the same or lower disease severity (P<0.001); whereas half of patients with Cs-At, compared with patients with no Cs-Cs and At-Cs, had disease progression at month 12. Throughout the study, dry eye signs and symptoms continuously improved in patients with Cs-Cs and At-Cs, whereas they constantly worsened in patients with Cs-At. At month 12, patients with Cs-Cs and At-Cs had significantly greater mean percentage improvement from baseline than did patients with Cs-At in Schirmer test scores, tear breakup time, Oxford staining scores, Ocular Surface Disease Index scores, and conjunctival goblet cell density (P<0.001). Overall, sign and symptom scores of patients with At-Cs did not improve as much as they did for patients with Cs-Cs. CONCLUSIONS: Cyclosporine 0.05% withdrawal led to disease progression, thus indicating the necessity for maintenance therapy. Earlier treatment with cyclosporine 0.05% may result in improved outcomes.


Subject(s)
Cyclosporine/therapeutic use , Dry Eye Syndromes/drug therapy , Immunosuppressive Agents/therapeutic use , Substance Withdrawal Syndrome , Cell Count , Cyclosporine/administration & dosage , Cyclosporine/adverse effects , Disease Progression , Drug Administration Schedule , Dry Eye Syndromes/pathology , Female , Goblet Cells/pathology , Humans , Immunosuppressive Agents/administration & dosage , Immunosuppressive Agents/adverse effects , Longitudinal Studies , Male , Middle Aged , Ophthalmic Solutions/administration & dosage , Ophthalmic Solutions/adverse effects , Ophthalmic Solutions/therapeutic use , Prospective Studies , Severity of Illness Index , Single-Blind Method
2.
J Ocul Pharmacol Ther ; 26(2): 157-64, 2010 Apr.
Article in English | MEDLINE | ID: mdl-20415623

ABSTRACT

PURPOSE: To assess the prognosis of dry eye in patients treated with cyclosporine 0.05% or artificial tears by using the International Task Force (ITF) guidelines. METHODS: This was a single-center, investigator-masked, prospective, randomized, longitudinal trial. Dry eye patients received twice-daily treatment with either cyclosporine 0.05% (Restasis; Allergan, Inc., Irvine, CA; n = 36) or artificial tears (Refresh Endura; Allergan, Inc., Irvine, CA; n = 22) for 12 months. Disease severity was determined at baseline and month 12 according to the consensus guidelines developed by the ITF. Dry eye signs and symptoms were evaluated at baseline and months 4, 8, and 12. RESULTS: Baseline sign and symptom scores and the proportion of patients with the disease severity level 2 or 3 were comparable in both groups (P > 0.05). At month 12, 34 of 36 cyclosporine patients (94%) and 15 of 22 artificial tear patients (68%) experienced improvements or no change in their disease severity (P = 0.007) while 2 of 36 cyclosporine patients (6%) and 7 of 22 artificial tears patients (32%) had disease progression (P < 0.01). Cyclosporine 0.05% improved Schirmer test scores, tear breakup time, and Ocular Surface Disease Index scores throughout the study, with significant (P < 0.01) differences compared with artificial tears being observed at months 8 and 12. CONCLUSIONS: Treatment with cyclosporine 0.05% may slow or prevent disease progression in patients with dry eye at severity levels 2 or 3.


Subject(s)
Cyclosporine/administration & dosage , Dry Eye Syndromes/prevention & control , Immunosuppressive Agents/administration & dosage , Administration, Topical , Adult , Cell Count , Disease Progression , Dry Eye Syndromes/physiopathology , Female , Follow-Up Studies , Goblet Cells/pathology , Humans , Male , Middle Aged , Ophthalmic Solutions/administration & dosage , Prognosis , Prospective Studies
4.
Cornea ; 25(6): 674-8, 2006 Jul.
Article in English | MEDLINE | ID: mdl-17077659

ABSTRACT

PURPOSE: To assess the efficacy of topical cyclosporine 0.05% (Restasis) in patients with dry eye associated with graft versus host disease after stem cell transplantation. METHODS: After completing a 3-month run-in period of using only artificial tears to control dry eye symptoms in both eyes, patients who failed to achieve adequate relief (n = 8) were instructed to instill topical cyclosporine twice a day. Visual acuity, slit-lamp appearance, and intraocular pressure were evaluated every 2 weeks for a minimum of 3 months. In addition, Schirmer basal secretion tests, noninvasive fluorescein breakup time, and tear lysozyme were also performed. Patients were also given a dry eye questionnaire regarding symptoms of burning, tearing, and blurred vision. RESULTS: Dry eye signs improved significantly with cyclosporine treatment in 7 of 8 patients. Cyclosporine provided statistically significant improvements in Schirmer basal secretion scores (P = 0.003), tear breakup time (P = 0.002), and tear lysozyme levels (P = 0.033) after 3 months of treatment. CONCLUSION: The findings in this prospective study suggest that dry eye associated with graft versus host disease can be effectively treated with topical cyclosporine, especially in patients unresponsive to other treatment modalities. These findings should be further evaluated in large-scale, controlled clinical trials.


Subject(s)
Cyclosporine/administration & dosage , Dry Eye Syndromes/drug therapy , Graft vs Host Disease/drug therapy , Immunosuppressive Agents/administration & dosage , Administration, Topical , Adult , Dry Eye Syndromes/etiology , Female , Graft vs Host Disease/complications , Humans , Male , Middle Aged , Muramidase/metabolism , Prospective Studies , Surveys and Questionnaires , Tears/metabolism , Treatment Outcome , Visual Acuity
5.
Am J Ophthalmol ; 141(4): 771-2, 2006 Apr.
Article in English | MEDLINE | ID: mdl-16564829

ABSTRACT

PURPOSE: To assess the efficacy of topical cyclosporine 0.05% (Restasis) in patients with herpes simplex virus nonnecrotizing stromal keratitis unresponsive to topical prednisolone. DESIGN: Prospective case series. METHODS: Patients with herpes simplex virus stromal keratitis (n = 12) that was unresponsive to topical prednisolone acetate 1% for at least four weeks were evaluated at a single site. Eyes were treated with topical cyclosporine twice a day and begun on a rapid prednisolone taper. Visual acuity, slit-lamp appearance, intraocular pressure, and corneal sensitivity were evaluated every two weeks for at least three months. RESULTS: Stromal keratitis resolved with cyclosporine in 10 of 12 patients after one month. The mean lesion area decreased more with cyclosporine than with prednisolone (2.0 mm with cyclosporine compared with 0.25 mm with prednisolone). After stopping cyclosporine therapy, four patients had recurrence of stromal keratitis. CONCLUSION: This series suggests that herpes simplex virus stromal keratitis can be treated effectively with topical cyclosporine, particularly in cases that are not responsive to topical prednisolone.


Subject(s)
Cyclosporine/therapeutic use , Immunosuppressive Agents/therapeutic use , Keratitis, Herpetic/drug therapy , Administration, Topical , Adult , Corneal Stroma/drug effects , Corneal Stroma/virology , Cyclosporine/administration & dosage , Humans , Immunosuppressive Agents/administration & dosage , Ophthalmic Solutions/administration & dosage , Ophthalmic Solutions/therapeutic use , Prednisolone/administration & dosage , Prednisolone/therapeutic use , Prospective Studies , Recurrence , Treatment Outcome , Visual Acuity
6.
J Ocul Pharmacol Ther ; 22(1): 47-53, 2006 Feb.
Article in English | MEDLINE | ID: mdl-16503775

ABSTRACT

We assessed the efficacy of topical cyclosporin 0.05% ophthalmic emulsion versus tobramycin 0.3%/dexamethasone 0.1% in patients with posterior blepharitis. Posterior blepharitis improved significantly from the initial study visit with both cyclosporin treatment and tobramycin/dexamethasone. Cyclosporin provided greater improvements in Schirmer's scores (P < 0.001) and tear break-up time (P = 0.018) than tobramycin/dexamethasone after 12 weeks of treatment. Eyelid health also improved in both groups, but the mean improvement in meibomian gland secretion quality was significantly greater with cyclosporin than with tobramycin/dexamethasone (P = 0.015). Moreover, a higher percentage of patients in the cyclosporin treatment group had improvements in symptoms of blurred vision, burning, and itching and more cyclosporin-treated patients experienced resolution of lid telangiectasia. The findings in this prospective study suggest that posterior blepharitis can be more effectively treated with cyclosporin than with tobramycin/dexamethasone. These findings should be further evaluated in large-scale, controlled, clinical trials.


Subject(s)
Blepharitis/drug therapy , Cyclosporine/administration & dosage , Administration, Topical , Anti-Bacterial Agents/therapeutic use , Anti-Inflammatory Agents/therapeutic use , Blepharitis/pathology , Dexamethasone/therapeutic use , Female , Humans , Immunosuppressive Agents , Male , Middle Aged , Ophthalmic Solutions , Prospective Studies , Tears/metabolism , Tobramycin/therapeutic use , Treatment Outcome
7.
Ophthalmology ; 109(9): 1642-6, 2002 Sep.
Article in English | MEDLINE | ID: mdl-12208710

ABSTRACT

OBJECTIVE: To evaluate the relationship between videokeratographic keratoconus screening programs and Orbscan II topography. DESIGN: Prospective, observational case series and instrument validation study. PARTICIPANTS: Sixty consecutive eyes with suspicious videokeratography (TMS-1, Tomey Technology, Waltham, MA) were evaluated before undergoing laser in situ keratomileusis (LASIK) surgery. A control group of 50 consecutive eyes without suspicious features by videokeratography was also evaluated. METHODS: Keratoconus screening programs, using the Rabinowitz and Klyce/Maeda methods and Orbscan II (Bausch & Lomb, Claremont, CA) topographies were performed on these patients. MAIN OUTCOME MEASURES: Specific parameters evaluated on the Orbscan II topographies were anterior elevation, posterior elevation, and thinnest pachymetry. RESULTS: Compared with a control group of patients without suspicious videokeratography, there was a statistically significant difference in the mean posterior elevation and mean anterior elevation in the groups with positive keratoconus testing with the Rabinowitz or Klyce/Maeda methods. For patients who met both the Rabinowitz and Klyce/Maeda criteria for keratoconus, the mean posterior elevation was 44 +/- 2.5 micro m compared with a posterior elevation of 21 +/- 0.6 micro m for the control group. There was no statistically significant difference in the mean thinnest pachymetry between the control group and all keratoconus suspect groups. CONCLUSIONS: Patients with positive keratoconus screening tests have higher anterior and posterior elevation on Orbscan II topography. When used in combination with videokeratography, the Orbscan II topography system may be helpful in identifying patients who are potentially at high risk for developing ectasia after LASIK.


Subject(s)
Cornea/pathology , Corneal Topography/methods , Keratoconus/diagnosis , Adult , Corneal Topography/instrumentation , Humans , Keratoconus/surgery , Keratomileusis, Laser In Situ , Preoperative Care/methods , Prospective Studies , Refractive Surgical Procedures
8.
J Refract Surg ; 18(4): 463-7, 2002.
Article in English | MEDLINE | ID: mdl-12160158

ABSTRACT

PURPOSE: To evaluate the effect of enlarging the temporal clear corneal cataract incision on pre-existing against-the-rule astigmatism. METHODS: We performed a prospective study of 21 eyes of 21 consecutive patients with astigmatism greater > or = 1.75 D, who underwent temporal clear corneal cataract surgery by phacoemulsification. Patients were divided into two groups. The first group, with medium astigmatism, consisted of 14 patients (14 eyes) with 1.75 to 2.74 D of against-the-rule astigmatism, and had an incision enlarged to 4.5 mm. The second group, with higher astigmatism, consisted of seven patients (seven eyes) with 2.75 to 3.75 D of against-the-rule astigmatism and had an incision enlarged to 5.5 mm. Corneal topography was performed preoperatively and 24 months postoperatively on all eyes. Surgically induced cylinder changes were compared by examining preoperative and postoperative keratometric power using vector analysis. RESULTS: Mean preoperative cylinder in the medium against-the-rule astigmatism group was 2.10 +/- 0.23 D and mean postoperative cylinder at 3 months was 1.17 +/- 0.29 D. Using vector analysis, mean change in cylinder in the medium group was 0.93 +/- 0.42 D (P < .001). In the higher against-the-rule astigmatism group, mean preoperative cylinder was 2.85 +/- 0.10 D and mean postoperative cylinder at 3 months was 1.63 +/- 0.38 D. Mean change in cylinder in the higher astigmatism group was 1.34 +/- 0.58 D (P < .001). For both groups, Student's t-test showed that the postoperative decrease in cylinder was statistically significant (P = .005). CONCLUSION: By enlarging the size of the standard (2.8 to 3.5 mm) temporal clear corneal cataract incision, pre-existing against-the-rule astigmatism was reduced.


Subject(s)
Astigmatism/surgery , Cornea/surgery , Phacoemulsification/methods , Astigmatism/etiology , Cataract/complications , Corneal Topography , Humans , Minimally Invasive Surgical Procedures , Preoperative Care , Prospective Studies , Treatment Outcome , Visual Acuity
9.
J Refract Surg ; 18(2): 177-84, 2002.
Article in English | MEDLINE | ID: mdl-11934208

ABSTRACT

PURPOSE: Laser in situ keratomileusis (LASIK) has been associated with the development of postoperative corneal ectasia. We present a case of early onset ectasia after LASIK, review known risk factors in development, and discuss possible strategies for prevention. METHODS: A 39-year-old man underwent bilateral LASIK for moderate myopia. Preoperative cycloplegic refractions were -9.00 + 0.25 x 140 degrees OD and -7.75 sphere OS. Corneal topography demonstrated mild inferior steepening bilaterally although definite evidence of keratoconus by either the Klyce/Maeda and Smolek/Klyce keratoconus screening tests was not present. Following the creation of flaps with 160-microm plates, ablations of 93 microm OD and 80 microm OS were performed, estimated to leave residual stromal beds of at least 314 microm OD and 330 microm OS. RESULTS: On the first postoperative day, uncorrected visual acuities were 20/400 OD and 20/40 OS. On the fifth postoperative day, the patient's uncorrected visual acuity was 20/400 OD, and 20/300 OS. Corneal topography of the right eye showed profound inferior steepening with an apical corneal power in excess of 57 D; topography of the left eye showed mild inferior steepening. Eighteen months after surgery best corrected visual acuity was 20/40 OD and 20/30 OS with rigid gas permeable contact lenses. CONCLUSIONS: This case highlights the need for a high index of suspicion when one notes an asymmetric bow-tie pattern on preoperative LASIK corneal topography, despite seemingly safe estimates of residual stromal bed thickness.


Subject(s)
Corneal Diseases/etiology , Keratomileusis, Laser In Situ/adverse effects , Adult , Corneal Topography , Dilatation, Pathologic/etiology , Humans , Iatrogenic Disease , Male , Myopia/surgery , Refraction, Ocular , Risk Factors , Visual Acuity
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