Macular PuckerNCT03934190
Inner Nuclear Macular Microcyst is a Risk Factor for Macular Cystoid Changes After Phacoemulsification in Eyes With Previous Vitrectomy and Macular Pucker Removal
An observational study of Macular Pucker and Macular Cyst, run by Changhua Christian Hospital.
Trial summary
To evaluate the visual acuity, macular thickness, morphological changes after cataract surgery in eyes with previous vitrectomy for macular pucker. Associated risk factors were also investigated. Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Macular Pucker, Macular Cyst
- How many people
- 46 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2014to 31 Mar 2019
- 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 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The general medical history of the patients was evaluated preoperatively. Comprehensive ophthalmological examinations including BCVA measurements and funduscopic examinations were performed at each visit. SD-OCT (Cirrus HD-OCT, Carl Zeiss Meditec, Dublin, CA) was used to measure the central macular thickness (CMT) and structural changes preoperatively, and at 1 day, 1 week, 1 month, 3 months, 6 months and 1 year postoperatively
Who may be able to join
- Patients had macular pucker surgery before cataract surgery.
- Follow up over 1 year.
Who cannot join
- Patients had any surgical complications such as posterior capsule rupture, vitreous loss, prolapse through the wound or iris trauma
- Patients had diabetes mellitus.
- Patients had uveitis or other inflammatory eye disease.
- Patients had history of retinal vein occlusion.
- Patients had retinal detachment; or previous vitrectomy for a disease other than macular pucker.
About this study
To evaluate the visual acuity, macular thickness, morphological changes after cataract surgery in eyes with previous vitrectomy for macular pucker. Associated risk factors were also investigated.
- Conditions
- Macular Pucker, Macular Cyst
- Keywords
- macular edema, pseudophakic cystoid macular edema, macular pucker, internal limiting membrane peeling, pars plana vitrectomy
- Medical subject headings
- Epiretinal Membrane, Macular Edema
What is being measured
The primary outcome is the main question the study is designed to answer.
Wilcoxon Signed-Rank test
A statistical comparison of average of different time point
Measured: 1 day, 1 week, 1 month, 3 months, 6 months and 1 year
Secondary outcomes (1)
visual acuity
visual acuity change in logMAR in different time point
Measured: 1 day, 1 week, 1 month, 3 months, 6 months and 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2019
- Study start1 Oct 2014
- Primary completion31 Jan 2019
- Study completion31 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Macular PuckerStudies 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
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Changhua Christian Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, San Ni Chen, Changhua Christian Hospital
- Investigators
- San-Ni Chen, MD, Principal investigator, Changhua Christian Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03934190
- Sponsor's protocol ID
- 141012
- Status last verified
- Apr 2019
- First submitted
- 29 Apr 2019
- Last updated
- 2 May 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inner Nuclear Macular Microcyst is a Risk Factor for Macular Cystoid Changes After Phacoemulsification in Eyes With Previous Vitrectomy and Macular Pucker Removal
- ClinicalTrials.gov ID
- NCT03934190
- Acronym / sponsor ID
- 141012
- Conditions
- Macular Pucker, Macular Cyst
- Keywords
- macular edema, pseudophakic cystoid macular edema, macular pucker, internal limiting membrane peeling, pars plana vitrectomy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Changhua Christian HospitalUniversity, hospital or other
- Study start
- 1 Oct 2014 (actual)
- Primary completion
- 31 Jan 2019 (actual)
- Study completion
- 31 Mar 2019 (actual)
- First posted
- 1 May 2019 (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 evaluate the visual acuity, macular thickness, morphological changes after cataract surgery in eyes with previous vitrectomy for macular pucker. Associated risk factors were also investigated.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The general medical history of the patients was evaluated preoperatively. Comprehensive ophthalmological examinations including BCVA measurements and funduscopic examinations were performed at each visit. SD-OCT (Cirrus HD-OCT, Carl Zeiss Meditec, Dublin, CA) was used to measure the central macular thickness (CMT) and structural changes preoperatively, and at 1 day, 1 week, 1 month, 3 months, 6 months and 1 year postoperatively
Key inclusion criteria (2 listed)
- Patients had macular pucker surgery before cataract surgery.
- Follow up over 1 year.
Key exclusion criteria (5 listed)
- Patients had any surgical complications such as posterior capsule rupture, vitreous loss, prolapse through the wound or iris trauma
- Patients had diabetes mellitus.
- Patients had uveitis or other inflammatory eye disease.
- Patients had history of retinal vein occlusion.
- Patients had retinal detachment; or previous vitrectomy for a disease other than macular pucker.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Wilcoxon Signed-Rank test
Time frame: 1 day, 1 week, 1 month, 3 months, 6 months and 1 year
A statistical comparison of average of different time point
1 secondary outcome
visual acuity
Time frame: 1 day, 1 week, 1 month, 3 months, 6 months and 1 year
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 2 May 2019.
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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.
San-Ni Chen, MD principal investigator
Changhua Christian Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Macular Pucker and Macular Cyst, run by Changhua Christian 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 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 2 May 2019. 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?
Wilcoxon Signed-Rank test (time frame: 1 day, 1 week, 1 month, 3 months, 6 months and 1 year). 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 2 May 2019.