A09F0401: Retinal Detachment After Lens Surgery in the Nearsighted

Sponsor
University Hospital, Bordeaux (Other)
Overall Status
Completed
CT.gov ID
NCT04072939
Collaborator
(none)
101
15

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Patients having had a lens surgery

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.

Study Design

Study Type:
Observational
Actual Enrollment :
101 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Study of the Incidence of Retinal Detachment After Lens Surgery in the Nearsighted
Actual Study Start Date :
May 31, 2005
Actual Primary Completion Date :
Aug 31, 2006
Actual Study Completion Date :
Aug 31, 2006

Arms and Interventions

Arm Intervention/Treatment
Single arm

dilated fundus exam

Other: Patients having had a lens surgery
Dilated fundus exam

Outcome Measures

Primary Outcome Measures

  1. Posterior detachment of vitreous yes/no [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.

  2. Posterior detachment of vitreous yes/no [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.

  3. Posterior detachment of vitreous yes/no [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.

  4. Posterior detachment of vitreous yes/no [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.

  5. Posterior detachment of vitreous yes/no [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.

  6. lesions of the retinal periphery yes/no [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.

  7. lesions of the retinal periphery yes/no [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.

  8. lesions of the retinal periphery yes/no [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.

  9. lesions of the retinal periphery yes/no [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.

  10. lesions of the retinal periphery yes/no [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.

  11. Argon laser treatment scars yes/no [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.

  12. Argon laser treatment scars yes/no [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.

  13. Argon laser treatment scars yes/no [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.

  14. Argon laser treatment scars yes/no [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.

  15. Argon laser treatment scars yes/no [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.

  16. tabby appearance without atrophy yes/no [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.

  17. tabby appearance without atrophy yes/no [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.

  18. tabby appearance without atrophy yes/no [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.

  19. tabby appearance without atrophy yes/no [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.

  20. tabby appearance without atrophy yes/no [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.

  21. 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 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.

  22. 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) [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.

  23. 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) [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.

  24. 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) [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.

  25. 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) [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 60 Years
Sexes Eligible for Study:
All
Accepts 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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • University Hospital, Bordeaux

Investigators

  • Principal Investigator: Joseph COLIN, Pr, Bordeaux University hsopital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University Hospital, Bordeaux
ClinicalTrials.gov Identifier:
NCT04072939
Other Study ID Numbers:
  • CHUBX 2004/03
First Posted:
Aug 28, 2019
Last Update Posted:
Aug 28, 2019
Last Verified:
Aug 1, 2019
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Keywords provided by University Hospital, Bordeaux
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 28, 2019