Clinical trial NCT04072939: Retinal Detachment After Lens Surgery in the Nearsighted
Official title: Study of the Incidence of Retinal Detachment After Lens Surgery in the Nearsighted
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Retinal Detachment
Lens Diseases
Short-Sighted
Keywords: Phacoemulsification
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
First posted: 2019-08-28
Enrollment: 101
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Strong myopic patients with lens surgery

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 years and preliminary results at 3 years.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Posterior detachment of vitreous yes/no
timeFrame: Preoperative time
measure: Posterior detachment of vitreous yes/no
timeFrame: 1 day after surgery
measure: Posterior detachment of vitreous yes/no
timeFrame: 1 week after surgery
measure: Posterior detachment of vitreous yes/no
timeFrame: 1 month after surgery
measure: Posterior detachment of vitreous yes/no
timeFrame: 3 months after surgery
measure: lesions of the retinal periphery yes/no
timeFrame: Preoperative time
measure: lesions of the retinal periphery yes/no
timeFrame: 1 day after surgery
measure: lesions of the retinal periphery yes/no
timeFrame: 1 week after surgery
measure: lesions of the retinal periphery yes/no
timeFrame: 1 month after surgery
measure: lesions of the retinal periphery yes/no
timeFrame: 3 months after surgery
measure: Argon laser treatment scars yes/no
timeFrame: Preoperative time
measure: Argon laser treatment scars yes/no
timeFrame: 1 day after surgery
measure: Argon laser treatment scars yes/no
timeFrame: 1 week after surgery
measure: Argon laser treatment scars yes/no
timeFrame: 1 month after surgery
measure: Argon laser treatment scars yes/no
timeFrame: 3 months after surgery
measure: tabby appearance without atrophy yes/no
timeFrame: Preoperative time
measure: tabby appearance without atrophy yes/no
timeFrame: 1 day after surgery
measure: tabby appearance without atrophy yes/no
timeFrame: 1 week after surgery
measure: tabby appearance without atrophy yes/no
timeFrame: 1 month after surgery
measure: tabby appearance without atrophy yes/no
timeFrame: 3 months after surgery
measure: 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)
timeFrame: Preoperative time
measure: 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)
timeFrame: 1 day after surgery
measure: 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)
timeFrame: 1 week after surgery
measure: 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)
timeFrame: 1 month after surgery
measure: 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)
timeFrame: 3 months after surgery
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Bordeaux University hsopital
name: Joseph COLIN, Pr
role: PRINCIPAL_INVESTIGATOR
References: