Retinal Detachment After Lens Surgery in the Nearsighted (A09F0401)

August 27, 2019 updated by: University Hospital, Bordeaux

Study of the Incidence of 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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
101

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

20 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Strong myopic patients with lens surgery

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Single arm
dilated fundus exam
Other: Patients having had a lens surgery
Dilated fundus exam

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Preoperative time
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.
1 day after surgery
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.
1 week after surgery
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.
1 month after surgery
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.
3 months after surgery
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.
Preoperative time
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.
1 day after surgery
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.
1 week after surgery
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.
1 month after surgery
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.
3 months after surgery
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.
Preoperative time
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.
1 day after surgery
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.
1 week after surgery
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.
1 month after surgery
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.
3 months after surgery
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.
Preoperative time
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.
1 day after surgery
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.
1 week after surgery
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.
1 month after surgery
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.
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)
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.
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)
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.
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)
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.
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)
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.
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)
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.
3 months after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital, Bordeaux

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Joseph COLIN, Pr, Bordeaux University Hsopital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 31, 2005

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 31, 2006

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 31, 2006

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 26, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 27, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 28, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 28, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 27, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CHUBX 2004/03

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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