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)

Inflammation Eye Clinical Trial

— FLAVIC  

Official title:

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)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03677700
• Other study ID #: 35RC18_3043_FLAVIC
• Status: Not yet recruiting
• Start date: September 2018
• Est. completion date: July 2020

Study information

• Verified date: May 2018
• Source: Rennes University Hospital
• Contact: Dalal ASRI
• Phone: 299284289
• Email: dalal.asri[@]chu-rennes.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: July 2020
• Est. primary completion date: July 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Endophthalmitis
• Inflammation
• Inflammation Eye

Intervention

Other:
• 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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Rennes University Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	Criteria associated with high inflammation	Identification of criteria associated with high inflammation : indication of surgery	Baseline (preoperatively)
Other	Criteria associated with high inflammation	Identification of criteria associated with high inflammation : ophthalmologic antecedents	Baseline (preoperatively)
Other	Criteria associated with high inflammation	Identification of criteria associated with high inflammation : high preoperative IOP	Baseline (preoperatively)
Other	Criteria associated with high inflammation	Identification of criteria associated with high inflammation : BCVA (better visual acuity corrected) preoperatively	Baseline (preoperatively)
Primary	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	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