Skip to content

Retinal Detachment After Lens Surgery in the Nearsighted

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04072939
Acronym
A09F0401
Enrollment
101
Registered
2019-08-28
Start date
2005-05-31
Completion date
2006-08-31
Last updated
2019-08-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lens Diseases, Retinal Detachment, Short-Sighted

Keywords

Phacoemulsification

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.

Interventions

OTHERPatients having had a lens surgery

Dilated fundus exam

Sponsors

University Hospital, Bordeaux
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
20 Years to 60 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Posterior detachment of vitreous yes/noPreoperative timeWith 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/noPreoperative timeWith 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/noPreoperative timeWith 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/noPreoperative timeWith 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)Preoperative timeWith 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.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026