Retinal DetachmentFLADESILNCT05053698
Evolution of Aqueous Flare in Rhegmatogenous Retinal Detachments Treated With Gas or Silicone Oil Tamponade.
An observational study of Retinal Detachment, run by Central Hospital, Nancy, France at 1 site in France.
Trial summary
To examine and to compare the evolution of aqueous flare from presentation until the third postoperative month in a series of consecutive patients who underwent primary vitrectomy for rhegmatogenous retinal detachment (RRD), in 4 groups of patients : Group 1 : 48 eyes primarily treated with gas tamponade Group 2 : 11… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Retinal Detachment
- What is being tested?
- Aqueous flare measurement
- How many people
- 48 participants
- Where
- 1 siteFrance
- Study dates
- 3 Jun 2020to 4 Jun 2021
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients addressed at the Ophthalmology Department for Rhegmatogenous Retinal Detachment and who matched the inclusion criteria.
Who may be able to join
- adult patients
- patients who underwent surgery for rhegmatogenous retinal detachment (silicone or gas tamponade)
- aqueous flare measurement carried out preoperatively and postoperatively at 2-4 weeks and 3 months
Who cannot join
- diabetic retinopathy
- glaucoma
- non rhegmatogenous retinal detachment
- active uveitis
- pseudoexfoliation syndrome.
Trial locations and contacts
1 site in 1 country.
About this study
To examine and to compare the evolution of aqueous flare from presentation until the third postoperative month in a series of consecutive patients who underwent primary vitrectomy for rhegmatogenous retinal detachment (RRD), in 4 groups of patients :
- Group 1 : 48 eyes primarily treated with gas tamponade
- Group 2 : 11 eyes primarily treated with silicone oil tamponade
- Sub-Group G1RG : 8 eyes among Group 1 treated with gas after relapse
- Sub-Group G1RS : 3 eyes among Group 1 treated with silicone oil after relapse
- Conditions
- Retinal Detachment
- Being tested
- Aqueous flare measurement
- Keywords
- Aqueous Flare, Retinal Detachment
- Medical subject headings
- Retinal Detachment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aqueous flare measurementOther
Aqueous flare was measured preoperatively and postoperatively with a laser flare-cell meter (LFCM ; Kowa FM-500, Kowa Company Ltd, Tokyo, Japan).
| Study group | Role | What they receive |
|---|---|---|
| Initial gas tamponade | Primary vitrectomy and fluid-air exchange with SF6 or C2F6 gas tamponade Receives: Other: Aqueous flare measurement | |
| Initial silicone oil tamponade | Primary vitrectomy and fluid-air exchange with silicone oil tamponade Receives: Other: Aqueous flare measurement | |
| Relapse treated with gas tamponade | Secondary vitrectomy and fluid-air exchange with SF6 or C2F6 or C3F8 gas tamponade Receives: Other: Aqueous flare measurement | |
| Relapse treated with silicone oil tamponade | Secondary vitrectomy and fluid-air exchange with silicone oil tamponade Receives: Other: Aqueous flare measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in aqueous flare measurement (expressed as photon counts per millisecond and measured with a laser flare-cell meter)
Aqueous flare was measured preoperatively and postoperatively at 2 weeks, 4 weeks and 3 months with a laser flare-cell meter, in patients treated for RRD
Measured: preoperatively and postoperatively at 2 weeks and 3 months after surgery
Secondary outcomes (5)
Change in aqueous flare measurement (measured with a laser flare-cell meter)
To describe the evolution of the aqueous humor flare between the postoperative visits at 2 weeks and at 3 months after retinal detachment surgery in each groups of patients.
Measured: postoperatively at 2 weeks and 3 months after surgery
Comparison of aqueous flare values (measured with a laser flare-cell meter) between patients who relapsed and patients who didn't relapse
To compare the preoperative flare measurements between patients without versus with recurrence among those treated with gas
Measured: preoperative
Evolution of measures of visual acuity
The best-corrected visual acuity (BCVA) was measured with projected-light Snellen charts and expressed in logMAR.
Measured: preoperatively and postoperatively at 3 months
Evolution of macular status
Evaluation of macular status with macular imaging by optical coherence tomography (Heidelberg Engineering)
Measured: preoperatively and postoperatively at 3 months
Relapsing status (yes or not)
Determined by careful fundus and peripheral retina examination.
Measured: at 3 months postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2021
- Study start3 Jun 2020
- Primary completion4 Jun 2021
- Study completion4 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Retinal DetachmentStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, BERROD Jean-Paul, Central Hospital, Nancy, France
- Investigators
- Jean-Paul BERROD, Professor MD, Principal investigator, Central Hospital, Nancy, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05053698
- Sponsor's protocol ID
- 2020PI209
- Acronym
- FLADESIL
- Status last verified
- Sep 2021
- First submitted
- 4 Jun 2021
- Last updated
- 22 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evolution of Aqueous Flare in Rhegmatogenous Retinal Detachments Treated With Gas or Silicone Oil Tamponade.
- ClinicalTrials.gov ID
- NCT05053698
- Acronym / sponsor ID
- FLADESIL / 2020PI209
- Conditions
- Retinal Detachment
- Keywords
- Aqueous Flare, Retinal Detachment
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 3 Jun 2020 (actual)
- Primary completion
- 4 Jun 2021 (actual)
- Study completion
- 4 Jun 2021 (actual)
- First posted
- 22 Sep 2021 (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 and to compare the evolution of aqueous flare from presentation until the third postoperative month in a series of consecutive patients who underwent primary vitrectomy for rhegmatogenous retinal detachment (RRD), in 4 groups of patients :
- Group 1 : 48 eyes primarily treated with gas tamponade
- Group 2 : 11 eyes primarily treated with silicone oil tamponade
- Sub-Group G1RG : 8 eyes among Group 1 treated with gas after relapse
- Sub-Group G1RS : 3 eyes among Group 1 treated with silicone oil after relapse
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Initial gas tamponade | – | Other: Aqueous flare measurementPrimary vitrectomy and fluid-air exchange with SF6 or C2F6 gas tamponade |
| Initial silicone oil tamponade | – | Other: Aqueous flare measurementPrimary vitrectomy and fluid-air exchange with silicone oil tamponade |
| Relapse treated with gas tamponade | – | Other: Aqueous flare measurementSecondary vitrectomy and fluid-air exchange with SF6 or C2F6 or C3F8 gas tamponade |
| Relapse treated with silicone oil tamponade | – | Other: Aqueous flare measurementSecondary vitrectomy and fluid-air exchange with silicone oil tamponade |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients addressed at the Ophthalmology Department for Rhegmatogenous Retinal Detachment and who matched the inclusion criteria.
Key inclusion criteria (3 listed)
- adult patients
- patients who underwent surgery for rhegmatogenous retinal detachment (silicone or gas tamponade)
- aqueous flare measurement carried out preoperatively and postoperatively at 2-4 weeks and 3 months
Key exclusion criteria (5 listed)
- diabetic retinopathy
- glaucoma
- non rhegmatogenous retinal detachment
- active uveitis
- pseudoexfoliation syndrome.
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 |
|---|---|---|
| Aqueous flare measurementAqueous flare was measured preoperatively and postoperatively with a laser flare-cell meter (LFCM ; Kowa FM-500, Kowa Company Ltd, Tokyo, Japan). | Other | Initial gas tamponade, Initial silicone oil tamponade, Relapse treated with gas tamponade, Relapse treated with silicone oil tamponade |
Primary outcome
Change in aqueous flare measurement (expressed as photon counts per millisecond and measured with a laser flare-cell meter)
Time frame: preoperatively and postoperatively at 2 weeks and 3 months after surgery
Aqueous flare was measured preoperatively and postoperatively at 2 weeks, 4 weeks and 3 months with a laser flare-cell meter, in patients treated for RRD
5 secondary outcomes
Change in aqueous flare measurement (measured with a laser flare-cell meter)
Time frame: postoperatively at 2 weeks and 3 months after surgery
Comparison of aqueous flare values (measured with a laser flare-cell meter) between patients who relapsed and patients who didn't relapse
Time frame: preoperative
Evolution of measures of visual acuity
Time frame: preoperatively and postoperatively at 3 months
Evolution of macular status
Time frame: preoperatively and postoperatively at 3 months
Relapsing status (yes or not)
Time frame: at 3 months postoperative
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 22 Sep 2021.
- Individual participant dataSharing planned: No
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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.
Jean-Paul BERROD, Professor MD principal investigator
Central Hospital, Nancy, France
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, run by Central Hospital, Nancy, France at 1 site in France.
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 3 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 22 Sep 2021. 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 France. 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?
Change in aqueous flare measurement (expressed as photon counts per millisecond and measured with a laser flare-cell meter) (time frame: preoperatively and postoperatively at 2 weeks and 3 months after surgery). 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 22 Sep 2021.