Evaluation of Inflammation of the Anterior Segment by Laser Flashmeter in Patients Having Undergone Surgery of the Posterior Segment (Vitrectomy or Preindentation) During the First Postoperative Year. (FLAVIC)

NCT ID: NCT03677700

Last Updated: 2018-09-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-09-30

Study Completion Date

2020-07-31

Brief Summary

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Observational study, monocentric, prospective, descriptive and comparative (eye operated vs fellow eye).

Detailed Description

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After surgery by vitrectomy or preindentation, an anti-inflammatory treatment is conventionally prescribed for a duration of 1 month. However, frequently, during the post-operative control at one month, there may be signs of ocular inflammation or symptoms of discomfort justifying the prolongation of post-operative treatment. A 2012 study evaluated post-operative flare follow-up in 22 vitrectomized patients for retinal detachment, and showed a significantly higher flare 3 months after surgery, compared to the other eye and pre-surgery value.

In this study, the investigators wish to study postoperative inflammation in patients operated for posterior segment ocular surgery (vitrectomy or preindentation) measured by laser flashmeter on a follow-up of one year.

Conditions

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Inflammation Eye

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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Laser Flare Meter

Measurement of the inflammation of the operated eye and the fellow eye before the surgery and at each post-surgery visit: D7, M1, M2, M3, M6, M12

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Major patient,
* Operation of vitrectomy or preindentation in the ophthalmology department of Rennes University Hospital for one of the following reasons:
* Retinal detachment, rhegmatogenous or not
* Combined surgery
* Membrane peeling
* Macular hole
* Optically targeted vitrectomy (Terson's syndrome, intravitreous haemorrhage)
* Covered by a health insurance system,
* Having received information on the protocol and not having expressed opposition to participating in the study

Exclusion Criteria

* Vitrectomy for endophthalmitis or posterior uveitis,
* Patient with vitreoretinal proliferation (grade B and C),
* Pregnant or nursing woman,
* Major patient subject to legal protection (safeguard of justice, guardianship, guardianship), person deprived of liberty.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Rennes University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Dalal ASRI

Role: PRINCIPAL_INVESTIGATOR

Rennes University Hospital

Central Contacts

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Dalal ASRI

Role: CONTACT

299284289 ext. +33

Coralie DOUDNIKOFF

Role: CONTACT

Other Identifiers

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35RC18_3043_FLAVIC

Identifier Type: -

Identifier Source: org_study_id

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