Retinal Detachment After Lens Surgery in the Nearsighted

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Study of the Incidence of Retinal Detachment After Lens Surgery in the Nearsighted

Conditions
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Retinal Detachment, Lens Diseases, Short-Sighted

Intervention / Treatment
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* Other: Patients having had a lens surgery


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Single arm<br>dilated fundus exam | Other: Patients having had a lens surgery<br>* Dilated fundus exam<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Posterior detachment of vitreous yes/no | 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. | Preoperative time | 
| Posterior detachment of vitreous yes/no | 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. | 1 day after surgery | 
| Posterior detachment of vitreous yes/no | 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. | 1 week after surgery | 
| Posterior detachment of vitreous yes/no | 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. | 1 month after surgery | 
| Posterior detachment of vitreous yes/no | 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. | 3 months after surgery | 
| lesions of the retinal periphery yes/no | 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. | Preoperative time | 
| lesions of the retinal periphery yes/no | 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. | 1 day after surgery | 
| lesions of the retinal periphery yes/no | 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. | 1 week after surgery | 
| lesions of the retinal periphery yes/no | 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. | 1 month after surgery | 
| lesions of the retinal periphery yes/no | 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. | 3 months after surgery | 
| Argon laser treatment scars yes/no | 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. | Preoperative time | 
| Argon laser treatment scars yes/no | 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. | 1 day after surgery | 
| Argon laser treatment scars yes/no | 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. | 1 week after surgery | 
| Argon laser treatment scars yes/no | 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. | 1 month after surgery | 
| Argon laser treatment scars yes/no | 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. | 3 months after surgery | 
| tabby appearance without atrophy yes/no | 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. | Preoperative time | 
| tabby appearance without atrophy yes/no | 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. | 1 day after surgery | 
| tabby appearance without atrophy yes/no | 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. | 1 week after surgery | 
| tabby appearance without atrophy yes/no | 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. | 1 month after surgery | 
| tabby appearance without atrophy yes/no | 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. | 3 months after surgery | 
| 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) | 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. | Preoperative time | 
| 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) | 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. | 1 day after surgery | 
| 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) | 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. | 1 week after surgery | 
| 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) | 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. | 1 month after surgery | 
| 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) | 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. | 3 months after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Phacoemulsification