Effect of Anti-inflammatory Topical Prednisolone, Nepafenac and Ketorolac in Intra-operative Mydriasis in Facetectomies
Recruitment status was Active, not recruiting
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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 |
- 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 |
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| Brazil | |
| Clínica Oftalmológica Zona Sul | |
| Recife, Pernambuco, Brazil, 51020-031 | |
| 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 May 16, 2013