Retinal DetachmentNCT03902795
Functional and Morphological Results of Rhegmatogenous Retinal Detachment Treated With Vitrectomy
An observational study of Retinal Detachment and Vitrectomy, run by Medical University of Lublin at 1 site in Poland.
Trial summary
To examine morphological and functional results after pars plana vitrectomy (PPV) with SF6 gas tamponade due to macula-on and macula-off rhegmatogenous retinal detachment (RRD) during six months of the follow-up. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Retinal Detachment, Vitrectomy
- What is being tested?
- Microperimetry and M-charts
- How many people
- 62 participants
- Where
- 1 sitePoland
- Study dates
- Mar 2016to Oct 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: The study included 62 eyes that underwent successful vitrectomy with SF6 tamponade with macula-on (34 eyes) and macula-off (28 eyes) RRD preoperatively.
Who may be able to join
- The diagnosed macula-on and macula-off rhegmatogenous retinal detachment.
Who cannot join
- history of uveitis,
- diabetic retinopathy,
- previous vitreoretinal surgery,
- glaucoma or eye trauma,
- retinal detachment combined with macular hole or proliferative vitreoretinopathy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Functional and Morphological Results of macula-on and Macula-off Rhegmatogenous Retinal Detachment Treated With Pars Plana Vitrectomy and Sulfur Hexafluoride Gas Tamponade
To examine morphological and functional results after pars plana vitrectomy (PPV) with SF6 gas tamponade due to macula-on and macula-off rhegmatogenous retinal detachment (RRD) during six months of the follow-up.
Read the detailed description
Background:
To examine morphological and functional results after pars plana vitrectomy (PPV) with SF6 gas tamponade due to macula-on and macula-off rhegmatogenous retinal detachment (RRD) during six months of the follow-up.
Methods:
The study included 62 eyes that underwent successful PPV with SF6 tamponade with macula-on (34 eyes) and macula-off (28 eyes) RRD preoperatively. The best-corrected visual acuity (BCVA), Amsler test, M-charts, optical coherence tomography (OCT) and microperimetry were performed at 1, 3 and 6 months postoperatively.
- Conditions
- Retinal Detachment, Vitrectomy
- Being tested
- Microperimetry, M-charts
- Keywords
- Rhegmatogenous retinal detachment, Vitrectomy, Metamorphopsia, M-charts, Microperimetry
- Medical subject headings
- Retinal Detachment, Vision Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MicroperimetryDiagnostic 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 62 eyes | Group of 62 eyes with rhegmatogenous retinal detachment who underwent successful vitrectomy with SF6 tamponade Receives: Diagnostic Test: Microperimetry; 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 standard Amsler test performs with black lines on the white background. The Amsler grid has been used so far for the qualitative assessment of the metamorphopsia since 1947.
Measured: 1 to 6 months
M-charts
The M-charts consist of 19 dashed lines with increasing distance between points in the range of 0.2 ° to 2.0 ° viewing angle. Matsumoto developed M-charts for quantitative metamorphopsia evaluation in macula diseases in 1990. M-charts provide more information than Amsler chart in regard to the horizontal and vertical lines.
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
Microperimetry
Microperimetry is a procedure to assess retinal sensitivity while fundus is directly examined; it enables exact correlation between macular pathology and corresponding functional abnormality.
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 posted4 Apr 2019
- Study startMar 2016
- Primary completionOct 2017
- Study completionOct 2017
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 Retinal DetachmentStudies 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
- 62 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
- NCT03902795
- Sponsor's protocol ID
- 0004
- Status last verified
- Apr 2019
- First submitted
- 1 Apr 2019
- Last updated
- 4 Apr 2019
- 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
Borowicz D, Nowomiejska K, Nowakowska D, Brzozowska A, Toro MD, Avitabile T, Junemann AG, Rejdak R. Functional and morphological results of treatment of macula-on and macula-off rhegmatogenous retinal detachment with pars plana vitrectomy and sulfur hexafluoride gas tamponade. BMC Ophthalmol. 2019 May 24;19(1):118. doi: 10.1186/s12886-019-1120-3.
PubMed 31126280
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional and Morphological Results of macula-on and Macula-off Rhegmatogenous Retinal Detachment Treated With Pars Plana Vitrectomy and Sulfur Hexafluoride Gas Tamponade
- ClinicalTrials.gov ID
- NCT03902795
- Acronym / sponsor ID
- 0004
- Conditions
- Retinal Detachment, Vitrectomy
- Keywords
- Rhegmatogenous retinal detachment, Vitrectomy, Metamorphopsia, M-charts, Microperimetry
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Medical University of LublinUniversity, hospital or other
- Study start
- Mar 2016
- Primary completion
- Oct 2017 (actual)
- Study completion
- Oct 2017 (actual)
- First posted
- 4 Apr 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 examine morphological and functional results after pars plana vitrectomy (PPV) with SF6 gas tamponade due to macula-on and macula-off rhegmatogenous retinal detachment (RRD) during six months of the follow-up.
Detailed description
Background:
To examine morphological and functional results after pars plana vitrectomy (PPV) with SF6 gas tamponade due to macula-on and macula-off rhegmatogenous retinal detachment (RRD) during six months of the follow-up.
Methods:
The study included 62 eyes that underwent successful PPV with SF6 tamponade with macula-on (34 eyes) and macula-off (28 eyes) RRD preoperatively. The best-corrected visual acuity (BCVA), Amsler test, M-charts, optical coherence tomography (OCT) and microperimetry were performed at 1, 3 and 6 months postoperatively.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group of 62 eyes | – | Diagnostic Test: Microperimetry, Diagnostic Test: M-chartsGroup of 62 eyes with rhegmatogenous retinal detachment who underwent successful vitrectomy with SF6 tamponade |
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- The study included 62 eyes that underwent successful vitrectomy with SF6 tamponade with macula-on (34 eyes) and macula-off (28 eyes) RRD preoperatively.
Key inclusion criteria (1 listed)
- The diagnosed macula-on and macula-off rhegmatogenous retinal detachment.
Key exclusion criteria (5 listed)
- history of uveitis,
- diabetic retinopathy,
- previous vitreoretinal surgery,
- glaucoma or eye trauma,
- retinal detachment combined with macular hole or proliferative vitreoretinopathy
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 |
|---|---|---|
| MicroperimetryMicroperimetry 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 62 eyes |
| 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 62 eyes |
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 standard Amsler test performs with black lines on the white background. The Amsler grid has been used so far for the qualitative assessment of the metamorphopsia since 1947.
M-charts
Time frame: 1 to 6 months
The M-charts consist of 19 dashed lines with increasing distance between points in the range of 0.2 ° to 2.0 ° viewing angle. Matsumoto developed M-charts for quantitative metamorphopsia evaluation in macula diseases in 1990. M-charts provide more information than Amsler chart in regard to the horizontal and vertical lines.
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.
Microperimetry
Time frame: 1 to 6 months
Microperimetry is a procedure to assess retinal sensitivity while fundus is directly examined; it enables exact correlation between macular pathology and corresponding functional abnormality.
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 4 Apr 2019.
- Derived from this study: PubMed 31126280Borowicz D, Nowomiejska K, Nowakowska D, Brzozowska A, Toro MD, Avitabile T, Junemann AG, Rejdak R. Functional and morphological results of treatment of macula-on and macula-off rhegmatogenous retinal detachment with pars plana vitrectomy and sulfur hexafluoride gas tamponade. BMC Ophthalmol. 2019 May 24;19(1):118. doi: 10.1186/s12886-019-1120-3.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Retinal Detachment and Vitrectomy, run by Medical University of Lublin at 1 site in Poland.
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 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 4 Apr 2019. 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 Poland. 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.
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 5 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 NCT03902795, 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 4 Apr 2019.