Pseudophakic Cystoid Macular Lesions After Uncomplicated Standard PhacoemulsificationNCT03106402
Pseudophakic Cystoid Macular Lesions After Uncomplicated Standard Phacoemulsification
An observational study of Pseudophakic Cystoid Macular Lesions After Uncomplicated Standard Phacoemulsification, run by Kyungpook National University Hospital.
Trial summary
To assess the incidence, risk factors and clinical courses of cystic macular lesions (CMLs) after uncomplicated phacoemulsification and evaluate the efficacy of topical NSAIDs on the prevention of pseudophakic cystic macular lesions Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Pseudophakic Cystoid Macular Lesions After Uncomplicated Standard Phacoemulsification
- What is being tested?
- topical bromfenac sodium hydrate
- How many people
- 316 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2013to 30 Jul 2015
- Phase
- Observational
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: This retrospective chart review was of consecutive patients who had phacoemulsification and were treated postoperatively at the Kyungpook National University Hospital, Daegu, Korea, from Oct 2013 to June 2015.
Who may be able to join
- patients who had phacoemulsification and were treated postoperatively at the Kyungpook National University Hospital, Daegu, Korea, from Oct 2013 to June 2015.
Who cannot join
- patients had complicated cataract surgery (eg, significant corneal edema, posterior capsule rupture, vitreous loss, dropped nuclear material, retained cortical material, or an IOL not placed in the capsular bag)
About this study
To assess the incidence, risk factors and clinical courses of cystic macular lesions (CMLs) after uncomplicated phacoemulsification and evaluate the efficacy of topical NSAIDs on the prevention of pseudophakic cystic macular lesions
Read the detailed description
344 Patients undergoing uncomplicated standard phacoemulsification at Kyungpook National University Hospital from 2013 to 2015 were reviewed. CMLs, which is any cystic fluid collections after cataract surgery, were confirmed by preoperative and postoperative optical coherence tomography(OCT) on preoperative, postoperative 1month and 3months examinations. CMLs were classified into two groups: cystic macular edema(CME) and microcystic macular edema(MME).
- Being tested
- topical bromfenac sodium hydrate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
topical bromfenac sodium hydrateDrug
| Study group | Role | What they receive |
|---|---|---|
| Treated with topical NSAID | 197 eyes of - patients were treated with topical bromfenac sodium hydrate (Bronuck®, Taejoon Pharm. LTD.) 2times a day starting 1 day before surgery and continued for 2 weeks after surgery. Receives: Drug: topical bromfenac sodium hydrate | |
| Treated without topical NSAID | 147 eyes did not receive topical NSAID after cataract surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of CMLs
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2017
- Study start1 Oct 2013
- Primary completion30 Jun 2015
- Study completion30 Jul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pseudophakic Cystoid Macular Lesions After Uncomplicated Standard 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
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 316 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kyungpook National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hong Kyun Kim, M.D, Kyungpook National University Hospital
- Investigators
- Hong Kyun Kim, M.D. PhD, Principal investigator, Kyungpook National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03106402
- Sponsor's protocol ID
- KyungpookNUH
- Status last verified
- Apr 2017
- First submitted
- 3 Apr 2017
- Last updated
- 10 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pseudophakic Cystoid Macular Lesions After Uncomplicated Standard Phacoemulsification
- ClinicalTrials.gov ID
- NCT03106402
- Acronym / sponsor ID
- KyungpookNUH
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 316 participants (actual)
- Lead sponsor
- Kyungpook National University HospitalUniversity, hospital or other
- Study start
- 1 Oct 2013 (actual)
- Primary completion
- 30 Jun 2015 (actual)
- Study completion
- 30 Jul 2015 (actual)
- First posted
- 10 Apr 2017 (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.
To assess the incidence, risk factors and clinical courses of cystic macular lesions (CMLs) after uncomplicated phacoemulsification and evaluate the efficacy of topical NSAIDs on the prevention of pseudophakic cystic macular lesions
Detailed description
344 Patients undergoing uncomplicated standard phacoemulsification at Kyungpook National University Hospital from 2013 to 2015 were reviewed. CMLs, which is any cystic fluid collections after cataract surgery, were confirmed by preoperative and postoperative optical coherence tomography(OCT) on preoperative, postoperative 1month and 3months examinations. CMLs were classified into two groups: cystic macular edema(CME) and microcystic macular edema(MME).
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treated with topical NSAID | – | Drug: topical bromfenac sodium hydrate197 eyes of - patients were treated with topical bromfenac sodium hydrate (Bronuck®, Taejoon Pharm. LTD.) 2times a day starting 1 day before surgery and continued for 2 weeks after surgery. |
| Treated without topical NSAID | – | –147 eyes did not receive topical NSAID after cataract surgery |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- This retrospective chart review was of consecutive patients who had phacoemulsification and were treated postoperatively at the Kyungpook National University Hospital, Daegu, Korea, from Oct 2013 to June 2015.
Key inclusion criteria (1 listed)
- patients who had phacoemulsification and were treated postoperatively at the Kyungpook National University Hospital, Daegu, Korea, from Oct 2013 to June 2015.
Key exclusion criteria (1 listed)
- patients had complicated cataract surgery (eg, significant corneal edema, posterior capsule rupture, vitreous loss, dropped nuclear material, retained cortical material, or an IOL not placed in the capsular bag)
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 |
|---|---|---|
| topical bromfenac sodium hydrate | Drug | Treated with topical NSAID |
Primary outcome
Incidence of CMLs
Time frame: 12 weeks
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 10 Apr 2017.
- Individual participant dataSharing planned: Undecided
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.
Hong Kyun Kim, M.D. PhD principal investigator
Kyungpook National University Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Pseudophakic Cystoid Macular Lesions After Uncomplicated Standard Phacoemulsification, run by Kyungpook National University Hospital.
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 1 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 10 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
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.
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?
Incidence of CMLs (time frame: 12 weeks). 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 10 Apr 2017.