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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2009 by Clinica Oftamologica Zona Sul.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Clinica Oftamologica Zona Sul
ClinicalTrials.gov Identifier:
NCT00865540
First received: March 18, 2009
Last updated: May 23, 2011
Last verified: March 2009
  Purpose

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.


Condition Intervention Phase
Cataract
Drug: prednisolone acetate 1%
Drug: ketorolac tromethamine 0.4%
Drug: nepafenac 0.1%
Drug: methylcellulose 0.5%
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Effect of Anti-inflammatory Topical Prednisolone Acetate 1%, Nepafenac of 0.1% and Ketorolac Tromethamine 0.4% in Intra-operative Mydriasis in Facetectomies

Resource links provided by NLM:


Further study details as provided by Clinica Oftamologica Zona Sul:

Primary Outcome Measures:
  • pupil size [ Time Frame: 1 day ] [ Designated as safety issue: Yes ]

Enrollment: 30
Study Start Date: March 2009
Estimated Study Completion Date: August 2011
Estimated Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: prednisolone acetate 1%
one drop every 8h two days before surgery
Drug: prednisolone acetate 1%
1 drop every 8h two days before surgery
Experimental: ketorolac tromethamine 0.4%
one drop every 8h two days before surgery
Drug: ketorolac tromethamine 0.4%
1 drop every 8h two days before surgery
Experimental: nepafenac 0.1%
one drop every 8h two days before surgery
Drug: nepafenac 0.1%
1 drop every 8h two days before surgery
Placebo Comparator: placebo
one drop every 8h two days before surgery
Drug: methylcellulose 0.5%
1 drop every 8h two days before surgery

Detailed 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).

  Eligibility

Ages Eligible for Study:   50 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00865540

Locations
Brazil
Clínica Oftalmológica Zona Sul
Recife, Pernambuco, Brazil, 51020-031
Sponsors and Collaborators
Clinica Oftamologica Zona Sul
Investigators
Principal Investigator: Alexandre P Costa, Pinto Clínica Oftalmológica Zona Sul
  More Information

No publications provided

Responsible Party: Alexandre Paashaus da Costa Pinto, Clínica Oftalmológica Zona Sul
ClinicalTrials.gov Identifier: NCT00865540     History of Changes
Other Study ID Numbers: OMB NO:0925-0586
Study First Received: March 18, 2009
Last Updated: May 23, 2011
Health Authority: Brazil: Ethics Committee
Brazil: Ministry of Health
Brazil: National Committee of Ethics in Research
Brazil: National Health Surveillance Agency

Keywords provided by Clinica Oftamologica Zona Sul:
cataract
pupillary dilation
anti-inflammatory
therapeutic use

Additional relevant MeSH terms:
Mydriasis
Cataract
Pupil Disorders
Eye Diseases
Lens Diseases
Methylprednisolone acetate
Prednisolone acetate
Anti-Inflammatory Agents
Prednisolone
Methylprednisolone
Methylprednisolone Hemisuccinate
Ketorolac Tromethamine
Ketorolac
Prednisolone hemisuccinate
Prednisolone phosphate
Therapeutic Uses
Pharmacologic Actions
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Gastrointestinal Agents
Neuroprotective Agents
Protective Agents

ClinicalTrials.gov processed this record on April 23, 2014