Primary Vitrectomy for the Treatment of Retinal Detachment in Highly Myopic

Postoperative Complications Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01480505
• Other study ID #: Brice 01
• Status: Completed
• Phase: N/A
• First received: November 21, 2011
• Last updated: November 28, 2011
• Start date: October 1999
• Est. completion date: February 2005

Study information

• Verified date: November 2011
• Source: Centre Hospitalier Universitaire Dijon
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Direction Générale de la Santé
• Study type: Observational

Clinical 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. 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 840
• Est. completion date: February 2005
• Est. primary completion date: February 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Intraocular Pressure,
• Postoperative Complications
• Retinal Detachment

Intervention

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.

Locations

Country	Name	City	State
France	Ophthalmology Department	Dijon	Burgundy

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire Dijon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		No