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

NCT00865540 | Unknown Phase 4 DMC

• 1 other identifier: OMB NO:0925-0586
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cataract

Keywords

cataract; pupillary dilation; anti-inflammatory; therapeutic use

Outcome Measures

Primary Outcomes (1)

• pupil size

  1 day

Study Arms (4)

prednisolone acetate 1%

EXPERIMENTAL

one drop every 8h two days before surgery

Drug: prednisolone acetate 1%

ketorolac tromethamine 0.4%

EXPERIMENTAL

one drop every 8h two days before surgery

Drug: ketorolac tromethamine 0.4%

nepafenac 0.1%

EXPERIMENTAL

one drop every 8h two days before surgery

Drug: nepafenac 0.1%

placebo

PLACEBO COMPARATOR

one drop every 8h two days before surgery

Drug: methylcellulose 0.5%

Interventions

prednisolone acetate 1% DRUG

1 drop every 8h two days before surgery

prednisolone acetate 1%

ketorolac tromethamine 0.4% DRUG

1 drop every 8h two days before surgery

ketorolac tromethamine 0.4%

nepafenac 0.1% DRUG

1 drop every 8h two days before surgery

nepafenac 0.1%

methylcellulose 0.5% DRUG

1 drop every 8h two days before surgery

placebo

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Clinica Oftamologica Zona Sul: lead

Study Sites (1)

Clínica Oftalmológica Zona Sul

Recife, Pernambuco, 51020-031, Brazil

Location

MeSH Terms

Conditions

Cataract; Mydriasis

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases; Pupil Disorders

Study Officials

• Alexandre P Costa, Pinto

  Clínica Oftalmológica Zona Sul

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 18, 2009
• First Posted: March 19, 2009
• Study Start: March 1, 2009
• Primary Completion: August 1, 2011
• Study Completion: August 1, 2011
• Last Updated: May 24, 2011

Record last verified: 2009-03

Locations

BR (1)