Completed

NCT Number: NCT04072939

Retinal Detachment After Lens Surgery in the Nearsighted

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Retinal Detachment Eye Diseases Lens Diseases Myopia Refractive Errors Retinal Diseases Short-Sighted

Age range

20 year–60 year

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Patients having had a lens surgery

Other

Dilated fundus exam

Primary outcomes

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.

Sponsors and collaborators

Lead sponsor

University Hospital, Bordeaux

Other

Registry information

Official study title

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

Acronym: A09F0401

Important dates

Study start: 2005
Primary completion: 2006
Study completion: 2006
First posted: Aug 28, 2019
Registry last updated: Aug 28, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed

Early VItrectomy in DENse Spontaneous Vitreous HEmorrhage

NCT04676256

Eye Diseases, Retinal Break

Paris, Île-de-France Region, France

View Trial Details

Completed

DOREFA (Retinal Detachment: Function and Anatomy)

NCT01767038

Eye Diseases, Retinal Detachment

Besançon, France

View Trial Details

Completed

Methotrexate in Retinal Detachment With Proliferative Vitreoretinopathy

NCT07058337

Eye Diseases, Retinal Detachment

Cairo, Egypt

View Trial Details

Completed

A Study of Fluoroquinolones Exposure and Collagen-Related Serious Adverse Events

NCT03479736

Achilles Tendon, Acute Aortic Syndrome

Titusville, New Jersey, United States

View Trial Details

Key information

Conditions

Age range

Sex eligibility

Study type

About this study

Who can participate

Treatment and study plan

Patients having had a lens surgery

Primary outcomes

Posterior detachment of vitreous yes/no

Posterior detachment of vitreous yes/no

Posterior detachment of vitreous yes/no

Posterior detachment of vitreous yes/no

Posterior detachment of vitreous yes/no

lesions of the retinal periphery yes/no

lesions of the retinal periphery yes/no

lesions of the retinal periphery yes/no

lesions of the retinal periphery yes/no

lesions of the retinal periphery yes/no

Argon laser treatment scars yes/no

Argon laser treatment scars yes/no

Argon laser treatment scars yes/no

Argon laser treatment scars yes/no

Argon laser treatment scars yes/no

tabby appearance without atrophy yes/no

tabby appearance without atrophy yes/no

tabby appearance without atrophy yes/no

tabby appearance without atrophy yes/no

tabby appearance without atrophy yes/no

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)

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)

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)

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)

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)

Sponsors and collaborators

Lead sponsor

Registry information

Official study title

Important dates

Related clinical trials

Early VItrectomy in DENse Spontaneous Vitreous HEmorrhage

DOREFA (Retinal Detachment: Function and Anatomy)

Methotrexate in Retinal Detachment With Proliferative Vitreoretinopathy

A Study of Fluoroquinolones Exposure and Collagen-Related Serious Adverse Events