CataractPhase 4NCT00865540
Effect of Anti-inflammatory Topical Prednisolone, Nepafenac and Ketorolac in Intra-operative Mydriasis in Facetectomies
A Phase 4 study testing prednisolone acetate 1%, ketorolac tromethamine 0.4% and nepafenac 0.1% in people with Cataract, run by Clinica Oftamologica Zona Sul at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Cataract
- What is being tested?
- prednisolone acetate 1%, ketorolac tromethamine 0.4% and nepafenac 0.1%
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteBrazil
- Study dates
- Mar 2009to Aug 2011
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Carriers of senile cataract (> 50 years of age) with indication for cataract extraction with implantation of intraocular lens, with local anesthesia
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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).
- Conditions
- Cataract
- Being tested
- prednisolone acetate 1%, ketorolac tromethamine 0.4%, nepafenac 0.1%, methylcellulose 0.5%
- Keywords
- cataract, pupillary dilation, anti-inflammatory, therapeutic use
- Medical subject headings
- Cataract, Mydriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
prednisolone acetate 1%Drug
1 drop every 8h two days before surgery
ketorolac tromethamine 0.4%Drug
1 drop every 8h two days before surgery
nepafenac 0.1%Drug
1 drop every 8h two days before surgery
methylcellulose 0.5%Drug
1 drop every 8h two days before surgery
| Study group | Role | What they receive |
|---|---|---|
| prednisolone acetate 1% | Experimental | one drop every 8h two days before surgery Receives: Drug: prednisolone acetate 1% |
| ketorolac tromethamine 0.4% | Experimental | one drop every 8h two days before surgery Receives: Drug: ketorolac tromethamine 0.4% |
| nepafenac 0.1% | Experimental | one drop every 8h two days before surgery Receives: Drug: nepafenac 0.1% |
| placebo | Placebo comparator | one drop every 8h two days before surgery Receives: Drug: methylcellulose 0.5% |
What is being measured
The primary outcome is the main question the study is designed to answer.
pupil size
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2009 (estimated)
- Study startMar 2009
- Primary completionAug 2011 (estimated)
- Study completionAug 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CataractStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clinica Oftamologica Zona Sul
- Sponsor type
- University, hospital or other
- Investigators
- Alexandre P Costa, Pinto, Principal investigator, Clínica Oftalmológica Zona Sul
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00865540
- Sponsor's protocol ID
- OMB NO:0925-0586
- Status last verified
- Mar 2009
- First submitted
- 18 Mar 2009
- Last updated
- 24 May 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00865540
- Acronym / sponsor ID
- OMB NO:0925-0586
- Conditions
- Cataract
- Keywords
- cataract, pupillary dilation, anti-inflammatory, therapeutic use
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Clinica Oftamologica Zona SulUniversity, hospital or other
- Study start
- Mar 2009
- Primary completion
- Aug 2011 (estimated)
- Study completion
- Aug 2011 (estimated)
- First posted
- 19 Mar 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| prednisolone acetate 1% | Experimental | Drug: prednisolone acetate 1%one drop every 8h two days before surgery |
| ketorolac tromethamine 0.4% | Experimental | Drug: ketorolac tromethamine 0.4%one drop every 8h two days before surgery |
| nepafenac 0.1% | Experimental | Drug: nepafenac 0.1%one drop every 8h two days before surgery |
| placebo | Placebo comparator | Drug: methylcellulose 0.5%one drop every 8h two days before surgery |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Carriers of senile cataract (> 50 years of age) with indication for cataract extraction with implantation of intraocular lens, with local anesthesia
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| prednisolone acetate 1%1 drop every 8h two days before surgery | Drug | prednisolone acetate 1% |
| ketorolac tromethamine 0.4%1 drop every 8h two days before surgery | Drug | ketorolac tromethamine 0.4% |
| nepafenac 0.1%1 drop every 8h two days before surgery | Drug | nepafenac 0.1% |
| methylcellulose 0.5%1 drop every 8h two days before surgery | Drug | placebo |
Primary outcome
pupil size
Time frame: 1 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexandre P Costa, Pinto principal investigator
Clínica Oftalmológica Zona Sul
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing prednisolone acetate 1%, ketorolac tromethamine 0.4% and nepafenac 0.1% in people with Cataract, run by Clinica Oftamologica Zona Sul at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 May 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pupil size (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 May 2011; AzTrials last refreshed its copy on 8 Nov 2026.