Status:

COMPLETED

Retinal Detachment After Lens Surgery in the Nearsighted

Lead Sponsor:

University Hospital, Bordeaux

Conditions:

Retinal Detachment

Lens Diseases

Eligibility:

All Genders

20-60 years

Brief Summary

This study aims to study the incidence of retinal detachment in the nearsighted myopic after phakoemulsification lens surgery and use of posterior chamber foldable soft implants with a follow-up of 5 ...

Detailed Description

Major advances have been made in the field of lens surgery over the last 20 years which has significantly reduced the per and postoperative complications of this surgery. Retinal detachment remains th...

Eligibility Criteria

Inclusion

  • Signed informed consent form.
  • Male or female aged 20 to 60 included.
  • Myopia: axile, united or bilateral.
  • Degree of myopia: Axial length of the eye to be operated ≥ 26 mm, measured by ultrasound A or B.
  • Preoperative visual acuity of the eye to be operated ≥ 0.2.
  • Crystalline eye to operate natural: clear or opacified (allowed: cataract complicating a myopic implant and cataract after corneal refractive surgery.

Exclusion

  • History of retinal detachment on the eye to be operated or the eye to help.
  • History of glaucoma of the eye to operate.
  • intraocular pressure of the eye to operate ≥ 21 mmHg.
  • History of diabetic retinopathy.
  • History of anterior or posterior intraocular inflammation in the year preceding surgery.
  • History of vitreoretinal syndrome (Stickler's disease ...).
  • Unstable systemic pathology in the month preceding the preoperative check-up (Visit 1) (example: uncontrolled hypertension, diabetes with abnormal glycemia, thyroid disorders, uncontrolled autoimmune diseases, etc.) or deemed by the investigator to be incompatible with the study (example: hepatic or renal insufficiency, all severe chronic organic diseases: metabolic, endocrine, neoplastic, hematological, etc., severe psychiatric diseases).
  • Pregnancy, breastfeeding.
  • History of filter surgery of the eye to be operated.
  • History of vitreoretinal surgery of the eye to be operated (authorized after Day 0).
  • Patient unable to understand the instructions of the study or not likely to comply with the course of the study and treatment.
  • Participation in another clinical trial in the month preceding the start of this study, at the same time as this study.
  • Patient not covered by the French social security system.
  • Major patient under guardianship.

Key Trial Info

Start Date :

May 31 2005

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

August 31 2006

Estimated Enrollment :

101 Patients enrolled

Trial Details

Trial ID

NCT04072939

Start Date

May 31 2005

End Date

August 31 2006

Last Update

August 28 2019

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