Cystoid Macular Edema After PhacoemulsificationPhase 2NCT03551808
Prophylactic Effect of Ketorolac Tromethamine on the Cystoid Macular Edema After Phacoemulsification in Diabetic Patients
A Phase 2 study testing using of Ketorolac Tromethamine Eye Drop in people with Cystoid Macular Edema After Phacoemulsification, run by Shahid Beheshti University of Medical Sciences at 1 site in Iran.
Trial summary
The aim of the study is determining the prophylactic effect of ketorolac tromethamine drop 0.5% eye drop on the functional and anatomical ocular characteristics of the diabetic patients after the phacoemulsification surgery. Read more about this study
- Who is it for?
- Ages 20 to 95 yearsHealthy volunteers can take part
- Conditions the study is for
- Cystoid Macular Edema After Phacoemulsification
- What is being tested?
- using of Ketorolac Tromethamine Eye Drop
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteIran
- Study dates
- 1 Jan 2017to 1 Jun 2018
- Phase
- Phase 2
- 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 20 to 95 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Diabetic patients (type II) with cataract
- Eligible patients at age range of 20 to 95 years old
Who cannot join
- Cases with a diabetic macular edema
- proliferative diabetic retinopathy
- history of intravitreal injection of bevacizumab and macular photocoagulation prior three months to the cataract surgery
- glaucoma
- refractive errors of more than ±6 diopters
- history of previous ocular surgery
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- ocular pathological disorders
- history of systemic diseases
- history of medications which have a side effect on the retinal thickness
- patients with a follow up of less than 6 months
- individuals with any intraoperative complications will be excluded from this study.
Trial locations and contacts
1 site in 1 country.
Iran1 site, 1 recruiting
- Recruiting
Study site
Tehran
Hossien Mohammad Rabie, MD, 9822591616, labbafi@hotmail.com
About this study
The aim of the study is determining the prophylactic effect of ketorolac tromethamine drop 0.5% eye drop on the functional and anatomical ocular characteristics of the diabetic patients after the phacoemulsification surgery. Cystoid macular edema (CME) is a ocular disease which the retinal thickness is increased by 30 % incidence at least or the visual acuity is decreased to 20/40 according to clinical definition. Ketorolac tromethamine is an non steroidal anti inflammatory medication which is used for treatment and Prophylactic for CME. Teh aim of this study is prophylactic effect of ketorolac tromethamine on choroidal and retinal thickness after Phacoemulsification in Diabetic Patients. In this randomized clinical trial, 102 eyes of 102 diabetic patients were included. All patients were undergone phacoemulsification surgery at Torfeh Eye Hospital between September 2015 and January 2017. To evaluate the prophylactic effect of ketorolac tromethamine topical eye drop, all cases were asked to apply it one day before the s:surgery in each 8 hours and continue it for 4 weeks after the surgery. Controls were not received placebo. All study population were examined using Snellen visual acuity chart, enhanced depth imaging optical coherence tomography (EDI-OCT). All patients were followed at 6, 12 and 24 weeks after the cataract surgery.
- Being tested
- using of Ketorolac Tromethamine Eye Drop
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
using of Ketorolac Tromethamine Eye DropDrug
using of Ketorolac Tromethamine Eye Drop one day before the surgery in each 8 hours and continue it for 4 weeks after the surgery
| Study group | Role | What they receive |
|---|---|---|
| installation of Ketorolac Tromethamine Eye Drop | Active comparator | Not described Receives: Drug: using of Ketorolac Tromethamine Eye Drop |
| not receiving placebo | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Best Corrected visual acuity
Snellen visual acuity chart
Measured: 24 weeks after the surgery
Secondary outcomes (1)
retinal and choroidal thickness
enhanced depth imaging optical coherence tomography (EDI-OCT)
Measured: 24 weeks after the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2018
- Study start1 Jan 2017
- Primary completion1 Jun 2017
- Study completion1 Jun 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cystoid Macular Edema After PhacoemulsificationStudies 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 102 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shahid Beheshti University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zahra Rabbani Khah, Shahid Beheshti University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03551808
- Sponsor's protocol ID
- 96316
- Status last verified
- Apr 2018
- First submitted
- 10 Apr 2018
- Last updated
- 11 Jun 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Mohammad-Rabei H, Sabbaghi H, Emamverdi M, Karimi S, Ramezani A, Nikkhah H, Kheiri B, Yaseri M, Sheibani K, Bahreini R. The effect of topical ketorolac tromethamine on macular thickening after phacoemulsification in diabetic patients. BMC Ophthalmol. 2023 Jul 14;23(1):320. doi: 10.1186/s12886-023-03077-y.
PubMed 37452330
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prophylactic Effect of Ketorolac Tromethamine on the Cystoid Macular Edema After Phacoemulsification in Diabetic Patients
- ClinicalTrials.gov ID
- NCT03551808
- Acronym / sponsor ID
- 96316
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 102 participants (estimated)
- Lead sponsor
- Shahid Beheshti University of Medical SciencesUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 1 Jun 2017 (actual)
- Study completion
- 1 Jun 2018 (estimated)
- First posted
- 11 Jun 2018 (actual)
- 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 aim of the study is determining the prophylactic effect of ketorolac tromethamine drop 0.5% eye drop on the functional and anatomical ocular characteristics of the diabetic patients after the phacoemulsification surgery. Cystoid macular edema (CME) is a ocular disease which the retinal thickness is increased by 30 % incidence at least or the visual acuity is decreased to 20/40 according to clinical definition. Ketorolac tromethamine is an non steroidal anti inflammatory medication which is used for treatment and Prophylactic for CME. Teh aim of this study is prophylactic effect of ketorolac tromethamine on choroidal and retinal thickness after Phacoemulsification in Diabetic Patients. In this randomized clinical trial, 102 eyes of 102 diabetic patients were included. All patients were undergone phacoemulsification surgery at Torfeh Eye Hospital between September 2015 and January 2017. To evaluate the prophylactic effect of ketorolac tromethamine topical eye drop, all cases were asked to apply it one day before the s:surgery in each 8 hours and continue it for 4 weeks after the surgery. Controls were not received placebo. All study population were examined using Snellen visual acuity chart, enhanced depth imaging optical coherence tomography (EDI-OCT). All patients were followed at 6, 12 and 24 weeks after the cataract surgery.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| installation of Ketorolac Tromethamine Eye Drop | Active comparator | Drug: using of Ketorolac Tromethamine Eye Drop |
| not receiving placebo | No intervention | – |
Who may qualify
- Ages
- 20 to 95 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diabetic patients (type II) with cataract
- Eligible patients at age range of 20 to 95 years old
Key exclusion criteria (11 listed)
- Cases with a diabetic macular edema
- proliferative diabetic retinopathy
- history of intravitreal injection of bevacizumab and macular photocoagulation prior three months to the cataract surgery
- glaucoma
- refractive errors of more than ±6 diopters
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 |
|---|---|---|
| using of Ketorolac Tromethamine Eye Dropusing of Ketorolac Tromethamine Eye Drop one day before the surgery in each 8 hours and continue it for 4 weeks after the surgery | Drug | installation of Ketorolac Tromethamine Eye Drop |
Primary outcome
Best Corrected visual acuity
Time frame: 24 weeks after the surgery
Snellen visual acuity chart
1 secondary outcome
retinal and choroidal thickness
Time frame: 24 weeks after the surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2018.
- Derived from this study: PubMed 37452330Mohammad-Rabei H, Sabbaghi H, Emamverdi M, Karimi S, Ramezani A, Nikkhah H, Kheiri B, Yaseri M, Sheibani K, Bahreini R. The effect of topical ketorolac tromethamine on macular thickening after phacoemulsification in diabetic patients. BMC Ophthalmol. 2023 Jul 14;23(1):320. doi: 10.1186/s12886-023-03077-y.
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing using of Ketorolac Tromethamine Eye Drop in people with Cystoid Macular Edema After Phacoemulsification, run by Shahid Beheshti University of Medical Sciences at 1 site in Iran.
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 11 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 11 Jun 2018. 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 Iran. 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Contact Hossien Mohammad Rabie, MD (9822591616, labbafi@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Best Corrected visual acuity (time frame: 24 weeks after the surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03551808, which also lists 1 linked publication.
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 11 Jun 2018.