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Primary Vitrectomy for the Treatment of Retinal Detachment in Highly Myopic

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ClinicalTrials.gov Identifier: NCT01480505
Recruitment Status : Completed
First Posted : November 29, 2011
Last Update Posted : November 29, 2011
Sponsor:
Information provided by (Responsible Party):
Nicot Frederic, Centre Hospitalier Universitaire Dijon

Brief 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. 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).


Condition or disease Intervention/treatment
Intraocular Pressure, Postoperative Complications Procedure: Pars plana vitrectomy with gas tamponade

Study Type : Observational
Actual Enrollment : 840 participants
Observational Model: Cohort
Time Perspective: Retrospective
Study Start Date : October 1999
Primary Completion Date : February 2005
Study Completion Date : February 2005

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U.S. FDA Resources

Group/Cohort Intervention/treatment
High myopic eye
Persons with high Myopia suffered from Rhegmatogenous Retinal detachment
Procedure: Pars plana vitrectomy with gas tamponade

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.




Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
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.
Criteria

Inclusion Criteria:

  • retinal detachment secondary to peripheral breaks (retinal tears, atrophic retinal hole)
  • secondary to posterior breaks (MH, PVT).

Exclusion Criteria: retinal detachment secondary to

  • severe eye injury,
  • diabetic retinopathy,
  • retinopathy of prematurity,
  • uveitis.

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01480505


Locations
France
Ophthalmology Department
Dijon, Burgundy, France, 21000
Sponsors and Collaborators
Centre Hospitalier Universitaire Dijon

Responsible Party: Nicot Frederic, Docteur, Centre Hospitalier Universitaire Dijon
ClinicalTrials.gov Identifier: NCT01480505     History of Changes
Other Study ID Numbers: Brice 01
First Posted: November 29, 2011    Key Record Dates
Last Update Posted: November 29, 2011
Last Verified: November 2011

Keywords provided by Nicot Frederic, Centre Hospitalier Universitaire Dijon:
Retinal detachment
high myopia
macular hole
axial length
Scleral buckling
Vitrectomy
Visual acuity
fundus examination results

Additional relevant MeSH terms:
Postoperative Complications
Retinal Detachment
Pathologic Processes
Retinal Diseases
Eye Diseases