Macular EdemaPhase 4PNKNCT01395069
Prophylactic Nepafenac and Ketorolac Versus Placebo in Patients Undergoing Cataract Surgery
A Phase 4 study testing Nepafenac 0.1% and Ketorolac 0.5% in people with Macular Edema, run by Queen's University at 1 site in Canada.
Trial summary
Assess prophylactic efficacy of topical non-steroidal anti-inflammatory drops in preventing macular edema. Patient undergoing uncomplicated cataract surgery will be enrolled and randomized to nepafenac, ketorolac, or placebo. Follow-up will occur at 1 month with ocular coherence tomography (OCT). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Macular Edema
- What is being tested?
- Nepafenac 0.1% and Ketorolac 0.5%
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 162 participants
- Where
- 1 siteCanada
- Study dates
- Feb 2010to May 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ability to give informed consent
- Age 18 years and older
Who cannot join
- Any pre-existing retinal disease (e.g., diabetic retinopathy, vein occlusion, exudative macular degeneration, etc.)
- Previous uveitis
- Previous intraocular surgery
- Allergy or hypersensitivity to NSAIDs
- Complicated cataract surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Clinical Trial Comparing Prophylactic Nepafenac 0.1% and Ketorolac 0.5% Versus Placebo in Preventing Postoperative Macular Edema After Uncomplicated Phacoemulsification Cataract Extraction (PNK)
Assess prophylactic efficacy of topical non-steroidal anti-inflammatory drops in preventing macular edema. Patient undergoing uncomplicated cataract surgery will be enrolled and randomized to nepafenac, ketorolac, or placebo. Follow-up will occur at 1 month with ocular coherence tomography (OCT).
- Conditions
- Macular Edema
- Being tested
- Nepafenac 0.1%, Ketorolac 0.5%, Placebo (sterile saline drops)
- Keywords
- Post-cataract surgery, macular edema
- Medical subject headings
- Macular Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nepafenac 0.1%Drug
1 drop QID for 1 month
Ketorolac 0.5%Drug
1 drop QID for 1 month
Placebo (sterile saline drops)Other
1 drop QID for 1 month
| Study group | Role | What they receive |
|---|---|---|
| Nepafenac 0.1% | Active comparator | Not described Receives: Drug: Nepafenac 0.1% |
| Ketorolac 0.5% | Active comparator | Not described Receives: Drug: Ketorolac 0.5% |
| Placebo | Placebo comparator | Not described Receives: Other: Placebo (sterile saline drops) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in macular volume (as quantified by OCT) at one month (compared to baseline)
Measured: baseline and one month after surgery
Secondary outcomes (1)
COMTOL health-related quality-of-life
Measured: one month after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2011 (estimated)
- Study startFeb 2010
- Primary completionMay 2011
- Study completionMay 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Macular EdemaStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 162 participants (actual)
Sponsor and investigators
- Lead sponsor
- Queen's University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Sherif R El-Defrawy, Queen's University
- Investigators
- Sherif El-Defrawy, MD PhD, Principal investigator, Queen's University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01395069
- Sponsor's protocol ID
- PNK
- Acronym
- PNK
- Status last verified
- Jan 2016
- First submitted
- 11 Jul 2011
- Last updated
- 13 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Clinical Trial Comparing Prophylactic Nepafenac 0.1% and Ketorolac 0.5% Versus Placebo in Preventing Postoperative Macular Edema After Uncomplicated Phacoemulsification Cataract Extraction (PNK)
- ClinicalTrials.gov ID
- NCT01395069
- Acronym / sponsor ID
- PNK / PNK
- Conditions
- Macular Edema
- Keywords
- Post-cataract surgery, macular edema
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 162 participants (actual)
- Lead sponsor
- Queen's UniversityUniversity, hospital or other
- Study start
- Feb 2010
- Primary completion
- May 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 15 Jul 2011 (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.
Assess prophylactic efficacy of topical non-steroidal anti-inflammatory drops in preventing macular edema. Patient undergoing uncomplicated cataract surgery will be enrolled and randomized to nepafenac, ketorolac, or placebo. Follow-up will occur at 1 month with ocular coherence tomography (OCT).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Nepafenac 0.1% | Active comparator | Drug: Nepafenac 0.1% |
| Ketorolac 0.5% | Active comparator | Drug: Ketorolac 0.5% |
| Placebo | Placebo comparator | Other: Placebo (sterile saline drops) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Ability to give informed consent
- Age 18 years and older
Key exclusion criteria (5 listed)
- Any pre-existing retinal disease (e.g., diabetic retinopathy, vein occlusion, exudative macular degeneration, etc.)
- Previous uveitis
- Previous intraocular surgery
- Allergy or hypersensitivity to NSAIDs
- Complicated cataract surgery
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 |
|---|---|---|
| Nepafenac 0.1%1 drop QID for 1 month | Drug | Nepafenac 0.1% |
| Ketorolac 0.5%1 drop QID for 1 month | Drug | Ketorolac 0.5% |
| Placebo (sterile saline drops)1 drop QID for 1 month | Other | Placebo |
Primary outcome
Change in macular volume (as quantified by OCT) at one month (compared to baseline)
Time frame: baseline and one month after surgery
1 secondary outcome
COMTOL health-related quality-of-life
Time frame: one month after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2016.
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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.
Sherif El-Defrawy, MD PhD principal investigator
Queen's University
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 Nepafenac 0.1% and Ketorolac 0.5% in people with Macular Edema, run by Queen's University at 1 site in Canada.
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 2 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: finished, as of the sponsor's last update on 13 Jan 2016. 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 Canada. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in macular volume (as quantified by OCT) at one month (compared to baseline) (time frame: baseline and one month after surgery). 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 13 Jan 2016.