Retinal Detachment After Lens Surgery in the Nearsighted (A09F0401)

University Hospital of Bordeaux

Status: Completed

Conditions: Retinal Detachment; Short-Sighted; Lens Diseases

Treatments: Other: Patients having had a lens surgery

Study type: Observational

Funder types: Other

Identifiers

NCT04072939

CHUBX 2004/03

Details and patient eligibility

About

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 years and preliminary results at 3 years.

Full 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 the most feared complication of this surgery in the nearsighted.

There is currently an increasing popularity in the international ophthalmic community for the correction of ametropia, particularly nearsightedness, by ablation of the non-cataracted lens, referred to as refractive lensectomy. However, no recent study reports the complications of this procedure with the use of modern surgical techniques.

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 years and preliminary results at 3 years.

Enrollment: 101 patients

Sex: All

Ages: 20 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 criteria

• 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.

Trial design

101 participants in 1 patient group

Single arm

Description:

dilated fundus exam

Treatment:

Other: Patients having had a lens surgery