Efficacy and Tolerability of a Combined Moxifloxacin/Dexamethasone Formulation for Topical Prophylaxis in Phacoemulsification: An Open-Label Single-Arm Clinical Trial
Background. The use of a fixed-combination antibiotic corticosteroid for infection prophylaxis in Asian patients undergoing phacoemulsification has not been reported. Methods. A 15-day, open-label, single-arm trial of 64 patients for phacoemulsification with intraocular lens (IOL) implantation is de...
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| Format: | Article |
| Language: | English |
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Wiley
2011-01-01
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| Series: | Journal of Ophthalmology |
| Online Access: | http://dx.doi.org/10.1155/2011/769571 |
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| author | Cesar Ramon G. Espiritu Mary Ellen A. Sy Tommee Lynne G. Tayengco |
| author_facet | Cesar Ramon G. Espiritu Mary Ellen A. Sy Tommee Lynne G. Tayengco |
| author_sort | Cesar Ramon G. Espiritu |
| collection | DOAJ |
| description | Background. The use of a fixed-combination antibiotic corticosteroid for infection prophylaxis in Asian patients undergoing phacoemulsification has not been reported. Methods. A 15-day, open-label, single-arm trial of 64 patients for phacoemulsification with intraocular lens (IOL) implantation is described. Patients applied moxifloxacin 0.5%/dexamethasone 0.1% (Vigadexa) eye drops four times daily before and until 15 days after surgery. Anterior chamber (AC) reaction, visual acuity, ocular pain and signs, and intraocular pressure (IOP) were assessed at baseline and on postoperative days 1, 3, 8, and 15. Results. At day 15, 55 (91.7%) patients scored 0 (<5 cells) in AC reaction. No surgery-related infection occurred. Mean best-corrected visual acuity improved 0.5 logMAR from baseline to 0.0 logMAR (P<.0001). Mean IOP remained at 12-13 mm Hg over the 15-day
treatment. Only 2 patients (3.1%) reported minimum ocular
pain. Two (3.1%) patients were shifted to prednisolone acetate
for severe inflammation. At the end of the study period, 8.3%
were given fluorometholone for 1 week for AC reaction grade
>0. No drug-related adverse event was reported.
Conclusion. Following phacoemulsification and IOL
implantation, the topical combination moxifloxacin
0.5%/dexamethasone 0.1% was effective in preventing
infection and controlling inflammation and was well
tolerated. |
| format | Article |
| id | doaj-art-f82b847bd69946ed90dc7fed0346671f |
| institution | Kabale University |
| issn | 2090-004X 2090-0058 |
| language | English |
| publishDate | 2011-01-01 |
| publisher | Wiley |
| record_format | Article |
| series | Journal of Ophthalmology |
| spelling | doaj-art-f82b847bd69946ed90dc7fed0346671f2025-02-03T01:03:33ZengWileyJournal of Ophthalmology2090-004X2090-00582011-01-01201110.1155/2011/769571769571Efficacy and Tolerability of a Combined Moxifloxacin/Dexamethasone Formulation for Topical Prophylaxis in Phacoemulsification: An Open-Label Single-Arm Clinical TrialCesar Ramon G. Espiritu0Mary Ellen A. Sy1Tommee Lynne G. Tayengco2American Eye Center, Level 5, Shangri-La Plaza, EDSA, Corner Shaw Boulevard, Ortigas Center, Mandaluyong City 1554, PhilippinesAmerican Eye Center, Level 5, Shangri-La Plaza, EDSA, Corner Shaw Boulevard, Ortigas Center, Mandaluyong City 1554, PhilippinesAmerican Eye Center, Level 5, Shangri-La Plaza, EDSA, Corner Shaw Boulevard, Ortigas Center, Mandaluyong City 1554, PhilippinesBackground. The use of a fixed-combination antibiotic corticosteroid for infection prophylaxis in Asian patients undergoing phacoemulsification has not been reported. Methods. A 15-day, open-label, single-arm trial of 64 patients for phacoemulsification with intraocular lens (IOL) implantation is described. Patients applied moxifloxacin 0.5%/dexamethasone 0.1% (Vigadexa) eye drops four times daily before and until 15 days after surgery. Anterior chamber (AC) reaction, visual acuity, ocular pain and signs, and intraocular pressure (IOP) were assessed at baseline and on postoperative days 1, 3, 8, and 15. Results. At day 15, 55 (91.7%) patients scored 0 (<5 cells) in AC reaction. No surgery-related infection occurred. Mean best-corrected visual acuity improved 0.5 logMAR from baseline to 0.0 logMAR (P<.0001). Mean IOP remained at 12-13 mm Hg over the 15-day treatment. Only 2 patients (3.1%) reported minimum ocular pain. Two (3.1%) patients were shifted to prednisolone acetate for severe inflammation. At the end of the study period, 8.3% were given fluorometholone for 1 week for AC reaction grade >0. No drug-related adverse event was reported. Conclusion. Following phacoemulsification and IOL implantation, the topical combination moxifloxacin 0.5%/dexamethasone 0.1% was effective in preventing infection and controlling inflammation and was well tolerated.http://dx.doi.org/10.1155/2011/769571 |
| spellingShingle | Cesar Ramon G. Espiritu Mary Ellen A. Sy Tommee Lynne G. Tayengco Efficacy and Tolerability of a Combined Moxifloxacin/Dexamethasone Formulation for Topical Prophylaxis in Phacoemulsification: An Open-Label Single-Arm Clinical Trial Journal of Ophthalmology |
| title | Efficacy and Tolerability of a Combined Moxifloxacin/Dexamethasone Formulation for Topical Prophylaxis in Phacoemulsification: An Open-Label Single-Arm Clinical Trial |
| title_full | Efficacy and Tolerability of a Combined Moxifloxacin/Dexamethasone Formulation for Topical Prophylaxis in Phacoemulsification: An Open-Label Single-Arm Clinical Trial |
| title_fullStr | Efficacy and Tolerability of a Combined Moxifloxacin/Dexamethasone Formulation for Topical Prophylaxis in Phacoemulsification: An Open-Label Single-Arm Clinical Trial |
| title_full_unstemmed | Efficacy and Tolerability of a Combined Moxifloxacin/Dexamethasone Formulation for Topical Prophylaxis in Phacoemulsification: An Open-Label Single-Arm Clinical Trial |
| title_short | Efficacy and Tolerability of a Combined Moxifloxacin/Dexamethasone Formulation for Topical Prophylaxis in Phacoemulsification: An Open-Label Single-Arm Clinical Trial |
| title_sort | efficacy and tolerability of a combined moxifloxacin dexamethasone formulation for topical prophylaxis in phacoemulsification an open label single arm clinical trial |
| url | http://dx.doi.org/10.1155/2011/769571 |
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