Retinal Detachment After Lens Surgery in the Nearsighted

Overview

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 Title of Study: “Study of the Incidence of Retinal Detachment After Lens Surgery in the Nearsighted”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: August 31, 2006

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 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.

Interventions

  • Other: Patients having had a lens surgery
    • Dilated fundus exam

Arms, Groups and Cohorts

  • Single arm
    • dilated fundus exam

Clinical Trial Outcome Measures

Primary Measures

  • Posterior detachment of vitreous yes/no
    • Time Frame: Preoperative time
    • With dilated fundus exam: the pupil will be dilated by instillation of a mydriatic eye drop. The bottom of the eye and the peripheral retina will be examined with a slit lamp with a Superfield lens or a glass with 3 mirrors.
  • Posterior detachment of vitreous yes/no
    • Time Frame: 1 day after surgery
    • With dilated fundus exam: the pupil will be dilated by instillation of a mydriatic eye drop. The bottom of the eye and the peripheral retina will be examined with a slit lamp with a Superfield lens or a glass with 3 mirrors.
  • Posterior detachment of vitreous yes/no
    • Time Frame: 1 week after surgery
    • With dilated fundus exam: the pupil will be dilated by instillation of a mydriatic eye drop. The bottom of the eye and the peripheral retina will be examined with a slit lamp with a Superfield lens or a glass with 3 mirrors.
  • Posterior detachment of vitreous yes/no
    • Time Frame: 1 month after surgery
    • With dilated fundus exam: the pupil will be dilated by instillation of a mydriatic eye drop. The bottom of the eye and the peripheral retina will be examined with a slit lamp with a Superfield lens or a glass with 3 mirrors.
  • Posterior detachment of vitreous yes/no
    • Time Frame: 3 months after surgery
    • With dilated fundus exam: the pupil will be dilated by instillation of a mydriatic eye drop. The bottom of the eye and the peripheral retina will be examined with a slit lamp with a Superfield lens or a glass with 3 mirrors.
  • lesions of the retinal periphery yes/no
    • Time Frame: Preoperative time
    • With dilated fundus exam: the pupil will be dilated by instillation of a mydriatic eye drop. The bottom of the eye and the peripheral retina will be examined with a slit lamp with a Superfield lens or a glass with 3 mirrors.
  • lesions of the retinal periphery yes/no
    • Time Frame: 1 day after surgery
    • With dilated fundus exam: the pupil will be dilated by instillation of a mydriatic eye drop. The bottom of the eye and the peripheral retina will be examined with a slit lamp with a Superfield lens or a glass with 3 mirrors.
  • lesions of the retinal periphery yes/no
    • Time Frame: 1 week after surgery
    • With dilated fundus exam: the pupil will be dilated by instillation of a mydriatic eye drop. The bottom of the eye and the peripheral retina will be examined with a slit lamp with a Superfield lens or a glass with 3 mirrors.
  • lesions of the retinal periphery yes/no
    • Time Frame: 1 month after surgery
    • With dilated fundus exam: the pupil will be dilated by instillation of a mydriatic eye drop. The bottom of the eye and the peripheral retina will be examined with a slit lamp with a Superfield lens or a glass with 3 mirrors.
  • lesions of the retinal periphery yes/no
    • Time Frame: 3 months after surgery
    • With dilated fundus exam: the pupil will be dilated by instillation of a mydriatic eye drop. The bottom of the eye and the peripheral retina will be examined with a slit lamp with a Superfield lens or a glass with 3 mirrors.
  • Argon laser treatment scars yes/no
    • Time Frame: Preoperative time
    • With dilated fundus exam: the pupil will be dilated by instillation of a mydriatic eye drop. The bottom of the eye and the peripheral retina will be examined with a slit lamp with a Superfield lens or a glass with 3 mirrors.
  • Argon laser treatment scars yes/no
    • Time Frame: 1 day after surgery
    • With dilated fundus exam: the pupil will be dilated by instillation of a mydriatic eye drop. The bottom of the eye and the peripheral retina will be examined with a slit lamp with a Superfield lens or a glass with 3 mirrors.
  • Argon laser treatment scars yes/no
    • Time Frame: 1 week after surgery
    • With dilated fundus exam: the pupil will be dilated by instillation of a mydriatic eye drop. The bottom of the eye and the peripheral retina will be examined with a slit lamp with a Superfield lens or a glass with 3 mirrors.
  • Argon laser treatment scars yes/no
    • Time Frame: 1 month after surgery
    • With dilated fundus exam: the pupil will be dilated by instillation of a mydriatic eye drop. The bottom of the eye and the peripheral retina will be examined with a slit lamp with a Superfield lens or a glass with 3 mirrors.
  • Argon laser treatment scars yes/no
    • Time Frame: 3 months after surgery
    • With dilated fundus exam: the pupil will be dilated by instillation of a mydriatic eye drop. The bottom of the eye and the peripheral retina will be examined with a slit lamp with a Superfield lens or a glass with 3 mirrors.
  • tabby appearance without atrophy yes/no
    • Time Frame: Preoperative time
    • With dilated fundus exam: the pupil will be dilated by instillation of a mydriatic eye drop. The bottom of the eye and the peripheral retina will be examined with a slit lamp with a Superfield lens or a glass with 3 mirrors.
  • tabby appearance without atrophy yes/no
    • Time Frame: 1 day after surgery
    • With dilated fundus exam: the pupil will be dilated by instillation of a mydriatic eye drop. The bottom of the eye and the peripheral retina will be examined with a slit lamp with a Superfield lens or a glass with 3 mirrors.
  • tabby appearance without atrophy yes/no
    • Time Frame: 1 week after surgery
    • With dilated fundus exam: the pupil will be dilated by instillation of a mydriatic eye drop. The bottom of the eye and the peripheral retina will be examined with a slit lamp with a Superfield lens or a glass with 3 mirrors.
  • tabby appearance without atrophy yes/no
    • Time Frame: 1 month after surgery
    • With dilated fundus exam: the pupil will be dilated by instillation of a mydriatic eye drop. The bottom of the eye and the peripheral retina will be examined with a slit lamp with a Superfield lens or a glass with 3 mirrors.
  • tabby appearance without atrophy yes/no
    • Time Frame: 3 months after surgery
    • With dilated fundus exam: the pupil will be dilated by instillation of a mydriatic eye drop. The bottom of the eye and the peripheral retina will be examined with a slit lamp with a Superfield lens or a glass with 3 mirrors.
  • Presence of eye anomaly yes/no (myopic conus, Bruch’s membrane breaks, deep chorioretinal atrophic cupboard with punch, deep choroidal atrophic cupboard showing sclera to bare)
    • Time Frame: Preoperative time
    • With dilated fundus exam: the pupil will be dilated by instillation of a mydriatic eye drop. The bottom of the eye and the peripheral retina will be examined with a slit lamp with a Superfield lens or a glass with 3 mirrors.
  • Presence of eye anomaly yes/no (myopic conus, Bruch’s membrane breaks, deep chorioretinal atrophic cupboard with punch, deep choroidal atrophic cupboard showing sclera to bare)
    • Time Frame: 1 day after surgery
    • With dilated fundus exam: the pupil will be dilated by instillation of a mydriatic eye drop. The bottom of the eye and the peripheral retina will be examined with a slit lamp with a Superfield lens or a glass with 3 mirrors.
  • Presence of eye anomaly yes/no (myopic conus, Bruch’s membrane breaks, deep chorioretinal atrophic cupboard with punch, deep choroidal atrophic cupboard showing sclera to bare)
    • Time Frame: 1 week after surgery
    • With dilated fundus exam: the pupil will be dilated by instillation of a mydriatic eye drop. The bottom of the eye and the peripheral retina will be examined with a slit lamp with a Superfield lens or a glass with 3 mirrors.
  • Presence of eye anomaly yes/no (myopic conus, Bruch’s membrane breaks, deep chorioretinal atrophic cupboard with punch, deep choroidal atrophic cupboard showing sclera to bare)
    • Time Frame: 1 month after surgery
    • With dilated fundus exam: the pupil will be dilated by instillation of a mydriatic eye drop. The bottom of the eye and the peripheral retina will be examined with a slit lamp with a Superfield lens or a glass with 3 mirrors.
  • Presence of eye anomaly yes/no (myopic conus, Bruch’s membrane breaks, deep chorioretinal atrophic cupboard with punch, deep choroidal atrophic cupboard showing sclera to bare)
    • Time Frame: 3 months after surgery
    • With dilated fundus exam: the pupil will be dilated by instillation of a mydriatic eye drop. The bottom of the eye and the peripheral retina will be examined with a slit lamp with a Superfield lens or a glass with 3 mirrors.

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 20 Years

Maximum Age: 60 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University Hospital, Bordeaux
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Joseph COLIN, Pr, Principal Investigator, Bordeaux University hsopital

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