Retinal Detachment After Lens Surgery in the Nearsighted

NCT04072939 | Completed

• 1 other identifier: CHUBX 2004/03
• Study Type: observational
• Target: 101
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Retinal Detachment; Lens Diseases; Short-Sighted

Keywords

Phacoemulsification

Outcome Measures

Primary Outcomes (25)

• 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

Study Arms (1)

Single arm

dilated fundus exam

Other: Patients having had a lens surgery

Interventions

Patients having had a lens surgery OTHER

Dilated fundus exam

Single arm

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Strong myopic patients with lens surgery

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Bordeaux: lead

MeSH Terms

Conditions

Retinal Detachment; Lens Diseases; Myopia

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases; Refractive Errors

Study Officials

• Joseph COLIN, Pr

  Bordeaux University hsopital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2019
• First Posted: August 28, 2019
• Study Start: May 31, 2005
• Primary Completion: August 31, 2006
• Study Completion: August 31, 2006
• Last Updated: August 28, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share