Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The main objective of this study is to compare the effect of preoperative use of anti-inflammatory topical prednisolone acetate 1%, nepafenac 0.1% and ketorolac tromethamine 0.4% of, plus a placebo, in maintaining the intra-operative mydriasis in extraction.
Will be conducted with a randomized clinical trial volunteers with indication of extraction in Recife, Brazil. The surgical technique is employed phacoemulsification with implantation of intraocular lens. Digital photos are taken of the eye at the beginning and end of surgery and with them will be digitally determined the relationship between the corneal area and pupillary area. Each volunteer will be drawn to one of four groups of study (group 1, prednisolone acetate 1%, group 2, of ketorolac tromethamine 0.4%, 0.1% nepafenac group 3 and group 4, placebo). For the volunteers randomly selected for each group will be prescribed medication in its presentation as eye drops (Prednisolone acetate 1%, Pred Fort ®, Allergan ®; of ketorolac tromethamine 0.4%, incite l ®, Allergan ®; Nepafenac 0.1%, Nevanac ® Alcon ® and 0.5% methylcellulose, Fresh Tears ®, Allergan ®), 01 drop every 8 hours for 48 hours before surgery. For all volunteers will also be prescribed gatifloxacin (Zymar ®), 01 drop every 8 hours starting 48 hours before surgery. Was scheduled a minimum sample of 60 volunteers (15 per group).
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| prednisolone acetate 1% | Experimental | one drop every 8h two days before surgery |
|
| ketorolac tromethamine 0.4% | Experimental | one drop every 8h two days before surgery |
|
| nepafenac 0.1% | Experimental | one drop every 8h two days before surgery |
|
| placebo | Placebo Comparator | one drop every 8h two days before surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| prednisolone acetate 1% | Drug | 1 drop every 8h two days before surgery |
| |
| Measure | Description | Time Frame |
|---|---|---|
| pupil size | 1 day |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Alexandre P Costa, Pinto | ClÃnica Oftalmológica Zona Sul | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ClÃnica Oftalmológica Zona Sul | Recife | Pernambuco | 51020-031 | Brazil |
Not provided
Not provided
Not provided
Not provided
Not provided
| ketorolac tromethamine 0.4% |
| Drug |
1 drop every 8h two days before surgery |
|
| nepafenac 0.1% | Drug | 1 drop every 8h two days before surgery |
|
| methylcellulose 0.5% | Drug | 1 drop every 8h two days before surgery |
|
| ID | Term |
|---|---|
| D002386 | Cataract |
| D015878 | Mydriasis |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
| D011681 | Pupil Disorders |
Not provided
Not provided