Effect of Anti-inflammatory Topical Prednisolone, Nepafenac and Ketorolac in Intra-operative Mydriasis in Facetectomies

Clinica Oftamologica Zona Sul

Status and phase: Unknown; Phase 4

Conditions: Cataract

Treatments: Drug: methylcellulose 0.5%; Drug: prednisolone acetate 1%; Drug: ketorolac tromethamine 0.4%; Drug: nepafenac 0.1%

Study type: Interventional

Funder types: Other

Identifiers

NCT00865540

OMB NO:0925-0586

Details and patient eligibility

About

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.

Full description

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).

Enrollment: 30 patients

Sex: All

Ages: 50 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Carriers of senile cataract (> 50 years of age) with indication for cataract extraction with implantation of intraocular lens, with local anesthesia

Exclusion criteria

• Diabetic
• Using systemic anti-hormonal and non-hormonal
• Using topical ocular medication (including anti-glaucomatous)
• Individuals with congenital ocular abnormalities and cases in which there is intra-operative complications (hernia or trauma in the iris, posterior capsule rupture or zônula and prolonged phacoemulsification time of ≥ 1 minute).
• Volunteers with incipient nuclear cataract (density 1) or advanced (density 4) by the LOCS II classification (density of nuclear cataract ranked 1 to 4 (Chalk et al, 1989)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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30 participants in 4 patient groups, including a placebo group

prednisolone acetate 1%

Experimental group

Description:

one drop every 8h two days before surgery

Treatment:

Drug: prednisolone acetate 1%

ketorolac tromethamine 0.4%

Experimental group

Description:

one drop every 8h two days before surgery

Treatment:

Drug: ketorolac tromethamine 0.4%

nepafenac 0.1%

Experimental group

Description:

one drop every 8h two days before surgery

Treatment:

Drug: nepafenac 0.1%

placebo

Placebo Comparator group

Description:

one drop every 8h two days before surgery

Treatment:

Drug: methylcellulose 0.5%