Effect of Anti-inflammatory Topical Prednisolone, Nepafenac and Ketorolac in Intra-operative Mydriasis in Facetectomies
Primary Purpose
Cataract
Status
Unknown status
Phase
Phase 4
Locations
Brazil
Study Type
Interventional
Intervention
prednisolone acetate 1%
ketorolac tromethamine 0.4%
nepafenac 0.1%
methylcellulose 0.5%
Sponsored by
About this trial
This is an interventional treatment trial for Cataract focused on measuring cataract, pupillary dilation, anti-inflammatory, therapeutic use
Eligibility 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)
Sites / Locations
- Clínica Oftalmológica Zona Sul
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Placebo Comparator
Arm Label
prednisolone acetate 1%
ketorolac tromethamine 0.4%
nepafenac 0.1%
placebo
Arm Description
one drop every 8h two days before surgery
one drop every 8h two days before surgery
one drop every 8h two days before surgery
one drop every 8h two days before surgery
Outcomes
Primary Outcome Measures
pupil size
Secondary Outcome Measures
Full Information
NCT ID
NCT00865540
First Posted
March 18, 2009
Last Updated
May 23, 2011
Sponsor
Clinica Oftamologica Zona Sul
1. Study Identification
Unique Protocol Identification Number
NCT00865540
Brief Title
Effect of Anti-inflammatory Topical Prednisolone, Nepafenac and Ketorolac in Intra-operative Mydriasis in Facetectomies
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2009
Overall Recruitment Status
Unknown status
Study Start Date
March 2009 (undefined)
Primary Completion Date
August 2011 (Anticipated)
Study Completion Date
August 2011 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Clinica Oftamologica Zona Sul
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataract
Keywords
cataract, pupillary dilation, anti-inflammatory, therapeutic use
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
prednisolone acetate 1%
Arm Type
Experimental
Arm Description
one drop every 8h two days before surgery
Arm Title
ketorolac tromethamine 0.4%
Arm Type
Experimental
Arm Description
one drop every 8h two days before surgery
Arm Title
nepafenac 0.1%
Arm Type
Experimental
Arm Description
one drop every 8h two days before surgery
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
one drop every 8h two days before surgery
Intervention Type
Drug
Intervention Name(s)
prednisolone acetate 1%
Intervention Description
1 drop every 8h two days before surgery
Intervention Type
Drug
Intervention Name(s)
ketorolac tromethamine 0.4%
Intervention Description
1 drop every 8h two days before surgery
Intervention Type
Drug
Intervention Name(s)
nepafenac 0.1%
Intervention Description
1 drop every 8h two days before surgery
Intervention Type
Drug
Intervention Name(s)
methylcellulose 0.5%
Intervention Description
1 drop every 8h two days before surgery
Primary Outcome Measure Information:
Title
pupil size
Time Frame
1 day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alexandre P Costa, Pinto
Organizational Affiliation
Clínica Oftalmológica Zona Sul
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clínica Oftalmológica Zona Sul
City
Recife
State/Province
Pernambuco
ZIP/Postal Code
51020-031
Country
Brazil
12. IPD Sharing Statement
Learn more about this trial
Effect of Anti-inflammatory Topical Prednisolone, Nepafenac and Ketorolac in Intra-operative Mydriasis in Facetectomies
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