Retinal DetachmentNCT06292572
Clinical Characteristics and Surgical Outcomes of the Fellow Eye in Bilateral Retinal Detachments
An observational study of Retinal Detachment, run by Central Hospital, Nancy, France at 1 site in France.
Trial summary
To assess the clinical features and the surgical outcomes of RD repair surgery of the fellow eye in bilateral retinal detachments 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?
- Retinal Detachment Surgery
- Type of treatment
- Surgery or procedure
- How many people
- 25 participants
- Where
- 1 siteFrance
- Study dates
- 1 Mar 2024to 1 Nov 2024
- 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 that underwent retinal detachment repair surgery for bilateral sequentiel retinal detachment between January 2016 and December 2023 at the Nancy Regional and University Hospital Center
Who may be able to join
- All patients that underwent retinal detachment repair surgery for bilateral sequential retinal detachment between January 2016 and December 2023 at the Nancy Regional and University Hospital Center (via pars plana vitrectomy or scleral buckling) and with a minimum of 6 month of post-operative follow-up after the last surgery.
Who cannot join
- Patients that underwent surgery at another facility
- Patients with a history of previous vitrectomy or
- Patients with a history of trauma from a penetrating injury or ruptured globe, retinal neovascular condition, hereditary vitreo-retinopathy
Trial locations and contacts
1 site in 1 country.
Jean-Baptiste Conart, MD, PhD contact
About this study
To assess the clinical features and the surgical outcomes of RD repair surgery of the fellow eye in bilateral retinal detachments
Read the detailed description
Bilateral retinal detachment is a rare but sight-threatening disease, that can cause blindness and poor quality of life.
It has been proved that patients who suffer from RD in one eye have a considerably increased risk to subsequently develop an RD in the fellow eye.
It can be expected that patients who experienced a RD in one eye, tend to present sooner when experiencing a RD in the fellow eye, and thus have a greater visual and/or anatomical prognosis.
In this study, we aim to describe characteristics of bilateral RD and compare the initial and subsequent eye in terms of clinical preoperative features, surgical management, and anatomical and visual results.
- Conditions
- Retinal Detachment
- Being tested
- Retinal Detachment Surgery
- Keywords
- retinal detachment, bilateral, vitrectomy
- Medical subject headings
- Retinal Detachment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Retinal Detachment SurgeryProcedure or surgery
Also called Pars plana Vitrectomy (PPV), Scleral Buckle (SB), PPV + SB
Retinal Detachment Surgery that consists in either Pars Plana Vitrectomy or Scleral Buckling or a combination of both techniques, and with or without use of intraocular tamponade
| Study group | Role | What they receive |
|---|---|---|
| Initial Retinal Detachment | First of both eyes of the same patient that underwent retinal detachment repair Receives: Procedure: Retinal Detachment Surgery | |
| Subsequent Retinal Detachment | Subsequent eye undergoing retinal detachment repair Receives: Procedure: Retinal Detachment Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of surgical success
Rate of succesful surgical repair of RD within the follow-up period
Measured: 6 month after surgery
Secondary outcomes (1)
Visual Acuity
LogMAR Visual acuity measured at the follow-up visit
Measured: 6 month after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2024
- Study start1 Mar 2024 (estimated)
- Primary completion1 Nov 2024 (estimated)
- Study completion1 Nov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- 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
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Professeur Jean-Baptiste CONART, Central Hospital, Nancy, France
- Investigators
- Jean-Baptiste Conart, MD, PhD, Principal investigator, CHRU de Nancy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06292572
- Sponsor's protocol ID
- 2024PI029
- Status last verified
- Feb 2024
- First submitted
- 27 Feb 2024
- Last updated
- 5 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Xu D, Belin PJ, Staropoli PC, Yannuzzi NA, Vangipuram G, Chiang A, Shah GK, Townsend JH, Ryan EH, Klufas MA. Clinical Outcomes in Sequential, Bilateral Rhegmatogenous Retinal Detachment: A Multicenter, Paired-Eye Analysis. Ophthalmol Retina. 2021 Aug;5(8):797-804. doi: 10.1016/j.oret.2020.11.002. Epub 2020 Nov 14.
PubMed 33197679Walia HS, Shah GK, Blinder KJ. Characteristics and outcomes of sequential rhegmatogenous retinal detachments. Ophthalmic Surg Lasers Imaging Retina. 2015 Apr;46(4):445-9. doi: 10.3928/23258160-20150422-07.
PubMed 25970865Mitry D, Singh J, Yorston D, Siddiqui MA, Murphy AL, Wright AF, Fleck BW, Campbell H, Charteris DG. The fellow eye in retinal detachment: findings from the Scottish Retinal Detachment Study. Br J Ophthalmol. 2012 Jan;96(1):110-3. doi: 10.1136/bjo.2010.194852. Epub 2011 Mar 3.
PubMed 21378003Radeck V, Schindler F, Helbig H, Gamulescu MA, Cvetkov Y, Barth T, Maerker D. Characteristics of Bilateral Retinal Detachment. Ophthalmologica. 2023;246(2):99-106. doi: 10.1159/000527625. Epub 2022 Oct 25.
PubMed 36282053Mastropasqua L, Carpineto P, Ciancaglini M, Falconio G, Gallenga PE. Treatment of retinal tears and lattice degenerations in fellow eyes in high risk patients suffering retinal detachment: a prospective study. Br J Ophthalmol. 1999 Sep;83(9):1046-9. doi: 10.1136/bjo.83.9.1046.
PubMed 10460773
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Characteristics and Surgical Outcomes of the Fellow Eye in Bilateral Retinal Detachments
- ClinicalTrials.gov ID
- NCT06292572
- Acronym / sponsor ID
- 2024PI029
- Conditions
- Retinal Detachment
- Keywords
- retinal detachment, bilateral, vitrectomy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 1 Mar 2024 (estimated)
- Primary completion
- 1 Nov 2024 (estimated)
- Study completion
- 1 Nov 2024 (estimated)
- First posted
- 5 Mar 2024 (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 clinical features and the surgical outcomes of RD repair surgery of the fellow eye in bilateral retinal detachments
Detailed description
Bilateral retinal detachment is a rare but sight-threatening disease, that can cause blindness and poor quality of life.
It has been proved that patients who suffer from RD in one eye have a considerably increased risk to subsequently develop an RD in the fellow eye.
It can be expected that patients who experienced a RD in one eye, tend to present sooner when experiencing a RD in the fellow eye, and thus have a greater visual and/or anatomical prognosis.
In this study, we aim to describe characteristics of bilateral RD and compare the initial and subsequent eye in terms of clinical preoperative features, surgical management, and anatomical and visual results.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Initial Retinal Detachment | – | Procedure: Retinal Detachment SurgeryFirst of both eyes of the same patient that underwent retinal detachment repair |
| Subsequent Retinal Detachment | – | Procedure: Retinal Detachment SurgerySubsequent eye undergoing retinal detachment repair |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients that underwent retinal detachment repair surgery for bilateral sequentiel retinal detachment between January 2016 and December 2023 at the Nancy Regional and University Hospital Center
Key inclusion criteria (1 listed)
- All patients that underwent retinal detachment repair surgery for bilateral sequential retinal detachment between January 2016 and December 2023 at the Nancy Regional and University Hospital Center (via pars plana vitrectomy or scleral buckling) and with a minimum of 6 month of post-operative follow-up after the last surgery.
Key exclusion criteria (3 listed)
- Patients that underwent surgery at another facility
- Patients with a history of previous vitrectomy or
- Patients with a history of trauma from a penetrating injury or ruptured globe, retinal neovascular condition, hereditary vitreo-retinopathy
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 |
|---|---|---|
| Retinal Detachment SurgeryAlso: Pars plana Vitrectomy (PPV), Scleral Buckle (SB), PPV + SBRetinal Detachment Surgery that consists in either Pars Plana Vitrectomy or Scleral Buckling or a combination of both techniques, and with or without use of intraocular tamponade | Procedure or surgery | Initial Retinal Detachment, Subsequent Retinal Detachment |
Primary outcome
Rate of surgical success
Time frame: 6 month after surgery
Rate of succesful surgical repair of RD within the follow-up period
1 secondary outcome
Visual Acuity
Time frame: 6 month after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2024.
- Background: PubMed 33197679Xu D, Belin PJ, Staropoli PC, Yannuzzi NA, Vangipuram G, Chiang A, Shah GK, Townsend JH, Ryan EH, Klufas MA. Clinical Outcomes in Sequential, Bilateral Rhegmatogenous Retinal Detachment: A Multicenter, Paired-Eye Analysis. Ophthalmol Retina. 2021 Aug;5(8):797-804. doi: 10.1016/j.oret.2020.11.002. Epub 2020 Nov 14.
- Background: PubMed 25970865Walia HS, Shah GK, Blinder KJ. Characteristics and outcomes of sequential rhegmatogenous retinal detachments. Ophthalmic Surg Lasers Imaging Retina. 2015 Apr;46(4):445-9. doi: 10.3928/23258160-20150422-07.
- Background: PubMed 21378003Mitry D, Singh J, Yorston D, Siddiqui MA, Murphy AL, Wright AF, Fleck BW, Campbell H, Charteris DG. The fellow eye in retinal detachment: findings from the Scottish Retinal Detachment Study. Br J Ophthalmol. 2012 Jan;96(1):110-3. doi: 10.1136/bjo.2010.194852. Epub 2011 Mar 3.
- Background: PubMed 36282053Radeck V, Schindler F, Helbig H, Gamulescu MA, Cvetkov Y, Barth T, Maerker D. Characteristics of Bilateral Retinal Detachment. Ophthalmologica. 2023;246(2):99-106. doi: 10.1159/000527625. Epub 2022 Oct 25.
- Background: PubMed 10460773Mastropasqua L, Carpineto P, Ciancaglini M, Falconio G, Gallenga PE. Treatment of retinal tears and lattice degenerations in fellow eyes in high risk patients suffering retinal detachment: a prospective study. Br J Ophthalmol. 1999 Sep;83(9):1046-9. doi: 10.1136/bjo.83.9.1046.
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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-Baptiste Conart, MD, PhD contact
Jean-Baptiste Conart, MD, PhD principal investigator
CHRU de Nancy
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 1 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 5 Mar 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ida Gordon (+33622820203, gordon.ida14@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of surgical success (time frame: 6 month after surgery). 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 NCT06292572, which also lists 5 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 5 Mar 2024.