Macular EdemaNCT00974753
Prophylactic Ketorolac Post Epiretinal Membrane Surgery
A study testing Ketorolac 0.5% and Saline drops in people with Macular Edema, run by Queen's University at 1 site in Canada.
Trial summary
Evaluate the efficacy of ketorolac 0.5%, a topical non-steroidal anti-inflammatory drug (NSAID), to prevent macular edema after epiretinal membrane surgery. Patients undergoing epiretinal membrane surgery have increased risk of macular swelling which can adversely affect vision. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Macular Edema
- What is being tested?
- Ketorolac 0.5% and Saline drops
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 18 participants
- Where
- 1 siteCanada
- Study dates
- Mar 2010to Mar 2012
- Phase
- Interventional
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- idiopathic epiretinal membrane diagnosis requiring membrane peel surgery
Who cannot join
- proliferative diabetic retinopathy
- sickle cell retinopathy
- radiation retinopathy
- choroidal folds
- hypersensitivity or allergy to NSAIDs
- wet macular degeneration
Show all 9Show fewer
- branch retinal vein occlusion (BRVO)
- central retinal vein occlusion (CRVO)
- complicated membrane peel surgery
Trial locations and contacts
1 site in 1 country.
Canada1 site
Department of Ophthalmology, Hotel Dieu Hospital, Queen's University
Kingston, Ontario, K7L 3N6
About this study
Official title: A Placebo-controlled, Randomized, Clinical Trial of Prophylactic Ketorolac 0.5% in Patients Undergoing Pars Plana Vitrectomy and Phacovitrectomy Epiretinal Membrane Peel Surgery: Assessing Macular Volume With Spectral-domain OCT
Evaluate the efficacy of ketorolac 0.5%, a topical non-steroidal anti-inflammatory drug (NSAID), to prevent macular edema after epiretinal membrane surgery. Patients undergoing epiretinal membrane surgery have increased risk of macular swelling which can adversely affect vision. Since post-intraocular surgery inflammation is a contributing factor to macular swelling and loss of vision, NSAID drops may be able to prevent or minimize the deleterious effects of macular swelling after epiretinal membrane surgery.
- Conditions
- Macular Edema
- Being tested
- Ketorolac 0.5%, Saline drops
- Keywords
- epiretinal membrane
- Medical subject headings
- Macular Edema, Epiretinal Membrane
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ketorolac 0.5%Drug
Also called ketorolac tromethamine, Apo-Ketorolac
Four-times a day starting one week before surgery and continued for 4 weeks post surgery.
Saline dropsOther
Four-times a day starting one week before surgery and continued for 4 weeks post surgery.
| Study group | Role | What they receive |
|---|---|---|
| PPV-MP + Placebo (Saline drops) | Placebo comparator | PPV-MP= pars plana vitrectomy membrane peel Receives: Other: Saline drops |
| PPV-MP + Ketorolac 0.5% | Active comparator | PPV-MP= pars plana vitrectomy membrane peel Receives: Drug: Ketorolac 0.5% |
| PhacoVit-MP + Placebo (Saline drops) | Placebo comparator | PhacoVit-MP= phacovitrectomy membrane peel Receives: Other: Saline drops |
| PhacoVit-MP + Ketorolac 0.5%. | Active comparator | PhacoVit-MP= phacovitrectomy membrane peel Receives: Drug: Ketorolac 0.5% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in macular volume from baseline.
Measured: Before surgery, at 1 week, 1 month, and 1 year after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2009 (estimated)
- Study startMar 2010
- Primary completionMar 2012
- Study completionMar 2012
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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Queen's University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jeff Gale, MD, FRCSC, Principal investigator, Queen's University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00974753
- Sponsor's protocol ID
- ERM-JG-2009
- Status last verified
- Jan 2016
- First submitted
- 8 Sep 2009
- 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
- A Placebo-controlled, Randomized, Clinical Trial of Prophylactic Ketorolac 0.5% in Patients Undergoing Pars Plana Vitrectomy and Phacovitrectomy Epiretinal Membrane Peel Surgery: Assessing Macular Volume With Spectral-domain OCT
- ClinicalTrials.gov ID
- NCT00974753
- Acronym / sponsor ID
- ERM-JG-2009
- Conditions
- Macular Edema
- Keywords
- epiretinal membrane
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Queen's UniversityUniversity, hospital or other
- Study start
- Mar 2010
- Primary completion
- Mar 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 10 Sep 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.
Evaluate the efficacy of ketorolac 0.5%, a topical non-steroidal anti-inflammatory drug (NSAID), to prevent macular edema after epiretinal membrane surgery. Patients undergoing epiretinal membrane surgery have increased risk of macular swelling which can adversely affect vision. Since post-intraocular surgery inflammation is a contributing factor to macular swelling and loss of vision, NSAID drops may be able to prevent or minimize the deleterious effects of macular swelling after epiretinal membrane surgery.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| PPV-MP + Placebo (Saline drops) | Placebo comparator | Other: Saline dropsPPV-MP= pars plana vitrectomy membrane peel |
| PPV-MP + Ketorolac 0.5% | Active comparator | Drug: Ketorolac 0.5%PPV-MP= pars plana vitrectomy membrane peel |
| PhacoVit-MP + Placebo (Saline drops) | Placebo comparator | Other: Saline dropsPhacoVit-MP= phacovitrectomy membrane peel |
| PhacoVit-MP + Ketorolac 0.5%. | Active comparator | Drug: Ketorolac 0.5%PhacoVit-MP= phacovitrectomy membrane peel |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- idiopathic epiretinal membrane diagnosis requiring membrane peel surgery
Key exclusion criteria (9 listed)
- proliferative diabetic retinopathy
- sickle cell retinopathy
- radiation retinopathy
- choroidal folds
- hypersensitivity or allergy to NSAIDs
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 |
|---|---|---|
| Ketorolac 0.5%Also: ketorolac tromethamine, Apo-KetorolacFour-times a day starting one week before surgery and continued for 4 weeks post surgery. | Drug | PPV-MP + Ketorolac 0.5%, PhacoVit-MP + Ketorolac 0.5%. |
| Saline dropsFour-times a day starting one week before surgery and continued for 4 weeks post surgery. | Other | PPV-MP + Placebo (Saline drops), PhacoVit-MP + Placebo (Saline drops) |
Primary outcome
Change in macular volume from baseline.
Time frame: Before surgery, at 1 week, 1 month, and 1 year 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.
Jeff Gale, MD, FRCSC 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 study testing Ketorolac 0.5% and Saline drops 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 1 inclusion and 9 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.
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 from baseline. (time frame: Before surgery, at 1 week, 1 month, and 1 year 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.