Macular HolesNCT03701542
The Application of M-charts and Microperimetry for the Assessment of Visual Function in Patients After Vitrectomy Due to the Full Thickness Macular Hole.
An observational study of Macular Holes and Microperymetry, run by Medical University of Lublin.
Trial summary
To examine the relationship between morphological and functional results in eyes after vitrectomy due to the full thickness macular hole (FTMH). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Macular Holes, Microperymetry, Vitrectomy
- What is being tested?
- Microperymetry and M-charts
- How many people
- 22 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2016to 31 Dec 2017
- 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
- Child, Adult, Older adult
Study population: 22 patients
Who may be able to join
- The diagnosed full thickness macular hole and psuedophakia.
Who cannot join
- macular pseudohole, non-full thickness macular hole, retinal detachment, other ocular comorbidities.
About this study
To examine the relationship between morphological and functional results in eyes after vitrectomy due to the full thickness macular hole (FTMH).
- Conditions
- Macular Holes, Microperymetry, Vitrectomy, M-charts
- Being tested
- Microperymetry, M-charts
- Keywords
- macular hole, microperymetry, vitrectomy, m-charts, metamorphopsia
- Medical subject headings
- Retinal Perforations, Vision Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MicroperymetryDiagnostic test
Microperimetry is a procedure to assess retinal sensitivity while fundus is directly examined; it enables exact correlation between macular pathology and corresponding functional abnormality.
M-chartsDiagnostic test
The M-chart (Inami Co., Tokyo, Japan) is a diagnostic tool developed by Matsumoto to quantify the degree of metamorphopsia in patients with macular diseases.
| Study group | Role | What they receive |
|---|---|---|
| Group of 22 patients | Group of 22 patients who underwent vitrectomy due to macular hole Receives: Diagnostic Test: Microperymetry; Diagnostic Test: M-charts |
What is being measured
The primary outcome is the main question the study is designed to answer.
The best-corrected visual acuity (BCVA)
Acuity is a measure of visual performance. The eye exam seeks to find the prescription that will provide the best corrected visual performance achievable
Measured: 1 to 6 months
Amsler test
The Amsler grid, consisting of evenly spaced horizontal and vertical lines, has been widely used since 1947 to test the metamorphopsia.
Measured: 1 to 6 months
Central retinal thickness
Quantitative thickness measurements derived from the "fast macular scan" algorithm report retinal thickness at several locations including the center point, central subfield, and 4 inner and 4 outer zones of the macula.
Measured: 1 to 6 months
Secondary outcomes (1)
Retinal sensitivity
Microperimetry is a procedure to assess retinal sensitivity while fundus is directly examined; it enables exact correlation between macular pathology and corresponding functional abnormality. It is a psychophysical method which is rapid, safe and non-invasive.
Measured: 1 to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2018
- Study start1 Jan 2016
- Primary completion31 Dec 2017
- Study completion31 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Macular HolesStudies 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
- Prospective
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Lublin
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03701542
- Sponsor's protocol ID
- 0003
- Status last verified
- Oct 2018
- First submitted
- 8 Oct 2018
- Last updated
- 10 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All data will be available in brief.
Publications
Wrzesinska D, Nowomiejska K, Nowakowska D, Toro MD, Bonfiglio V, Reibaldi M, Avitabile T, Rejdak R. Secondary Vitrectomy with Internal Limiting Membrane Plug due to Persistent Full-Thickness Macular Hole OCT-Angiography and Microperimetry Features: Case Series. J Ophthalmol. 2020 Sep 21;2020:2650873. doi: 10.1155/2020/2650873. eCollection 2020.
PubMed 33029387Wrzesinska D, Nowomiejska K, Nowakowska D, Brzozowska A, Avitabile T, Reibaldi M, Rejdak R, Toro M. Vertical and Horizontal M-Charts and Microperimetry for Assessment of the Visual Function in Patients after Vitrectomy with ILM Peeling due to Stage 4 Macular Hole. J Ophthalmol. 2019 May 6;2019:4975973. doi: 10.1155/2019/4975973. eCollection 2019.
PubMed 31198606
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Application of M-charts and Microperimetry for the Assessment of Visual Function in Patients After Vitrectomy Due to the Full Thickness Macular Hole.
- ClinicalTrials.gov ID
- NCT03701542
- Acronym / sponsor ID
- 0003
- Conditions
- Macular Holes, Microperymetry, Vitrectomy, M-charts
- Keywords
- macular hole, microperymetry, vitrectomy, m-charts, metamorphopsia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Medical University of LublinUniversity, hospital or other
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 31 Dec 2017 (actual)
- Study completion
- 31 Dec 2017 (actual)
- First posted
- 10 Oct 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.
To examine the relationship between morphological and functional results in eyes after vitrectomy due to the full thickness macular hole (FTMH).
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group of 22 patients | – | Diagnostic Test: Microperymetry, Diagnostic Test: M-chartsGroup of 22 patients who underwent vitrectomy due to macular hole |
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- 22 patients
Key inclusion criteria (1 listed)
- The diagnosed full thickness macular hole and psuedophakia.
Key exclusion criteria (1 listed)
- macular pseudohole, non-full thickness macular hole, retinal detachment, other ocular comorbidities.
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 |
|---|---|---|
| MicroperymetryMicroperimetry is a procedure to assess retinal sensitivity while fundus is directly examined; it enables exact correlation between macular pathology and corresponding functional abnormality. | Diagnostic test | Group of 22 patients |
| M-chartsThe M-chart (Inami Co., Tokyo, Japan) is a diagnostic tool developed by Matsumoto to quantify the degree of metamorphopsia in patients with macular diseases. | Diagnostic test | Group of 22 patients |
Primary outcome
The best-corrected visual acuity (BCVA)
Time frame: 1 to 6 months
Acuity is a measure of visual performance. The eye exam seeks to find the prescription that will provide the best corrected visual performance achievable
Amsler test
Time frame: 1 to 6 months
The Amsler grid, consisting of evenly spaced horizontal and vertical lines, has been widely used since 1947 to test the metamorphopsia.
Central retinal thickness
Time frame: 1 to 6 months
Quantitative thickness measurements derived from the "fast macular scan" algorithm report retinal thickness at several locations including the center point, central subfield, and 4 inner and 4 outer zones of the macula.
1 secondary outcome
Retinal sensitivity
Time frame: 1 to 6 months
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 Oct 2018.
- Derived from this study: PubMed 33029387Wrzesinska D, Nowomiejska K, Nowakowska D, Toro MD, Bonfiglio V, Reibaldi M, Avitabile T, Rejdak R. Secondary Vitrectomy with Internal Limiting Membrane Plug due to Persistent Full-Thickness Macular Hole OCT-Angiography and Microperimetry Features: Case Series. J Ophthalmol. 2020 Sep 21;2020:2650873. doi: 10.1155/2020/2650873. eCollection 2020.
- Derived from this study: PubMed 31198606Wrzesinska D, Nowomiejska K, Nowakowska D, Brzozowska A, Avitabile T, Reibaldi M, Rejdak R, Toro M. Vertical and Horizontal M-Charts and Microperimetry for Assessment of the Visual Function in Patients after Vitrectomy with ILM Peeling due to Stage 4 Macular Hole. J Ophthalmol. 2019 May 6;2019:4975973. doi: 10.1155/2019/4975973. eCollection 2019.
- Individual participant dataSharing planned: Yes. All data will be available in brief.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Macular Holes and Microperymetry, run by Medical University of Lublin.
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 Oct 2018. 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?
The best-corrected visual acuity (BCVA) (time frame: 1 to 6 months). The study lists 3 primary outcomes in all. 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 NCT03701542, which also lists 2 linked publications.
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 Oct 2018.