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) (FLAVIC)

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

Study Overview

• Status: Unknown
• Conditions: Inflammation Eye
• Intervention / Treatment: Other: Laser Flare Meter

Detailed Description

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.

• Study Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

• Study Contact: Name: Dalal ASRI; Phone Number: +33 299284289; Email: dalal.asri@chu-rennes.fr
• Study Contact Backup: Name: Coralie DOUDNIKOFF; Email: coralie.doudnikoff@chu-rennes.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Major patient undergoing vitrectomy or preindentation in the ophthalmology department of Rennes University Hospital

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evolution of the flare value	Evolution of the flare value preoperatively and then to D7, M1, M2, M3, M6, M12 of the operated eye	Changes between baseline (preoperatively) and day 7, month 1, month 2, month 3, month 6, and month 12 measures

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Flare values of the fellow eye and the operated eye	Flare value of the fellow eye and the operated eye at each evaluation time	Difference between flare values of the fellow eye and the operated eye at each evaluation time : baseline (preoperatively), day 7, month 1, month 2, month 3, month 6, and month 12

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Flare value of the operated eye	Flare value of the operated eye preoperatively and at each evaluation time	Changes between baseline (preoperatively) and day 7, month 1, month 2, month 3, month 6, and month 12 measures
Criteria associated with high inflammation	Identification of criteria associated with high inflammation : indication of surgery	Baseline (preoperatively)
Criteria associated with high inflammation	Identification of criteria associated with high inflammation : ophthalmologic antecedents	Baseline (preoperatively)
Criteria associated with high inflammation	Identification of criteria associated with high inflammation : high preoperative IOP	Baseline (preoperatively)
Criteria associated with high inflammation	Identification of criteria associated with high inflammation : BCVA (better visual acuity corrected) preoperatively	Baseline (preoperatively)

Collaborators and Investigators

• Sponsor: Rennes University Hospital
• Investigators: Principal Investigator: Dalal ASRI, Rennes University Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): September 1, 2018
• Primary Completion (Anticipated): July 1, 2020
• Study Completion (Anticipated): July 1, 2020

Study Registration Dates

• First Submitted: May 17, 2018
• First Submitted That Met QC Criteria: September 17, 2018
• First Posted (Actual): September 19, 2018

Study Record Updates

• Last Update Posted (Actual): September 19, 2018
• Last Update Submitted That Met QC Criteria: September 17, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Keywords: vitrectomy; cryoindentation
• Additional Relevant MeSH Terms: Pathologic Processes; Inflammation
• Other Study ID Numbers: 35RC18_3043_FLAVIC

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No