Intraocular Pressure,NCT01480505
Primary Vitrectomy for the Treatment of Retinal Detachment in Highly Myopic
An observational study of Intraocular Pressure, and Postoperative Complications, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
Trial summary
Purpose: To assess the functional and anatomical outcome of primary vitrectomy without scleral buckling for rhegmatogenous retinal detachment (RRD) in highly myopic eyes with axial length over 30 mm. Methods Design: Retrospective single center series. Setting: University Hospital. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Intraocular Pressure,, Postoperative Complications
- What is being tested?
- Pars plana vitrectomy with gas tamponade
- Type of treatment
- Surgery or procedure
- How many people
- 840 participants
- Where
- 1 siteFrance
- Study dates
- Oct 1999to Feb 2005
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: On the basis of axial length greater than 30 mm, 67 eyes of 67 patients with at least six-month follow-up in our department were selected.
Who may be able to join
- retinal detachment secondary to peripheral breaks (retinal tears, atrophic retinal hole)
- secondary to posterior breaks (MH, PVT).
Who cannot join
- severe eye injury,
- diabetic retinopathy,
- retinopathy of prematurity,
- uveitis.
Trial locations and contacts
1 site in 1 country.
About this study
Purpose:
To assess the functional and anatomical outcome of primary vitrectomy without scleral buckling for rhegmatogenous retinal detachment (RRD) in highly myopic eyes with axial length over 30 mm.
Methods Design: Retrospective single center series. Setting: University Hospital. Patients: High myopic patients treated with primary vitrectomy without scleral buckling for a rhegmatogenous retinal detachment.
Outcome measures: Anatomical success rate with complete reattachment of the retina without silicone oil tamponade and postoperative best-corrected visual acuity (BCVA).
- Conditions
- Intraocular Pressure,, Postoperative Complications
- Being tested
- Pars plana vitrectomy with gas tamponade
- Keywords
- Retinal detachment, high myopia, macular hole, axial length, Scleral buckling, Vitrectomy, Visual acuity, fundus examination results
- Medical subject headings
- Postoperative Complications, Retinal Detachment, Retinal Perforations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pars plana vitrectomy with gas tamponadeProcedure or surgery
A standard three-port 20 Gauge vitrectomy under a wide-angle-viewing contact lens was performed. Peripheral vitreous shaving was completed under slit-lamp illumination without contact lens by gentle scleral indentation. Posterior hyaloid detachment was checked and completed if necessary without dye. The epiretinal membrane removal or internal limiting membrane (ILM) peeling was performed if necessary. In general this latter procedure was not conducted for RD secondary to peripheral retinal tears without any sign of PVR or ERM but was done in almost all cases related to posterior break.
Subretinal fluid was aspirated through the retinal tear, the MH, the PVT or through a retinotomy to obtain a complete peroperative retinal reattachment.
| Study group | Role | What they receive |
|---|---|---|
| High myopic eye | Persons with high Myopia suffered from Rhegmatogenous Retinal detachment Receives: Procedure: Pars plana vitrectomy with gas tamponade |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessing the functional and anatomical outcome of primary vitrectomy in Rhegmatogenous retinal detachment in highly myopic eyes
To assess by visual acuity measurements, fundus ophthalmoscopy and OCT scans the functional and anatomical outcome in patients with higly myopic eyes whom we performed primary vitrectomy without scleral buckling for rhegmatogenous retinal detachment (RRD)in comparison to standard surgical technics wich consist on scleral buckling and pars plana vitrectomy with fluid gas exchange.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2011 (estimated)
- Study startOct 1999
- Primary completionFeb 2005
- Study completionFeb 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intraocular Pressure,Studies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire DijonThe 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
- 840 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Dijon
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nicot Frederic, Centre Hospitalier Universitaire Dijon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01480505
- Sponsor's protocol ID
- Brice 01
- Status last verified
- Nov 2011
- First submitted
- 21 Nov 2011
- Last updated
- 29 Nov 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Primary Vitrectomy for the Treatment of Retinal Detachment in Highly Myopic
- ClinicalTrials.gov ID
- NCT01480505
- Acronym / sponsor ID
- Brice 01
- Conditions
- Intraocular Pressure,, Postoperative Complications
- Keywords
- Retinal detachment, high myopia, macular hole, axial length, Scleral buckling, Vitrectomy, Visual acuity, fundus examination results
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 840 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire DijonUniversity, hospital or other
- Study start
- Oct 1999
- Primary completion
- Feb 2005 (actual)
- Study completion
- Feb 2005 (actual)
- First posted
- 29 Nov 2011 (estimated)
- 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.
Purpose:
To assess the functional and anatomical outcome of primary vitrectomy without scleral buckling for rhegmatogenous retinal detachment (RRD) in highly myopic eyes with axial length over 30 mm.
Methods Design: Retrospective single center series. Setting: University Hospital. Patients: High myopic patients treated with primary vitrectomy without scleral buckling for a rhegmatogenous retinal detachment.
Outcome measures: Anatomical success rate with complete reattachment of the retina without silicone oil tamponade and postoperative best-corrected visual acuity (BCVA).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| High myopic eye | – | Procedure: Pars plana vitrectomy with gas tamponadePersons with high Myopia suffered from Rhegmatogenous Retinal detachment |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- On the basis of axial length greater than 30 mm, 67 eyes of 67 patients with at least six-month follow-up in our department were selected.
Key inclusion criteria (2 listed)
- retinal detachment secondary to peripheral breaks (retinal tears, atrophic retinal hole)
- secondary to posterior breaks (MH, PVT).
Key exclusion criteria (4 listed)
- severe eye injury,
- diabetic retinopathy,
- retinopathy of prematurity,
- uveitis.
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 |
|---|---|---|
| Pars plana vitrectomy with gas tamponadeA standard three-port 20 Gauge vitrectomy under a wide-angle-viewing contact lens was performed. Peripheral vitreous shaving was completed under slit-lamp illumination without contact lens by gentle scleral indentation. Posterior hyaloid detachment was checked and completed if necessary without dye. The epiretinal membrane removal or internal limiting membrane (ILM) peeling was performed if necessary. In general this latter procedure was not conducted for RD secondary to peripheral retinal tears without any sign of PVR or ERM but was done in almost all cases related to posterior break. Subretinal fluid was aspirated through the retinal tear, the MH, the PVT or through a retinotomy to obtain a complete peroperative retinal reattachment. | Procedure or surgery | High myopic eye |
Primary outcome
Assessing the functional and anatomical outcome of primary vitrectomy in Rhegmatogenous retinal detachment in highly myopic eyes
To assess by visual acuity measurements, fundus ophthalmoscopy and OCT scans the functional and anatomical outcome in patients with higly myopic eyes whom we performed primary vitrectomy without scleral buckling for rhegmatogenous retinal detachment (RRD)in comparison to standard surgical technics wich consist on scleral buckling and pars plana vitrectomy with fluid gas exchange.
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 29 Nov 2011.
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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 Intraocular Pressure, and Postoperative Complications, run by Centre Hospitalier Universitaire Dijon 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 2 inclusion and 4 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 29 Nov 2011. 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?
Assessing the functional and anatomical outcome of primary vitrectomy in Rhegmatogenous retinal detachment in highly myopic eyes. 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 29 Nov 2011.