Evaluation of a Standardized Strategy for Uveitis Etiological Diagnosis

NCT01162070 | Completed DMC

• 1 other identifier: 2009.566/19
• Study Type: interventional
• Target: 905
• Locations: 1 country
• Sites: 1

Brief Summary

The Uveitis, the inflammation of the uvea, is a rare disease with an incidence of 52/100,000 inhabitants per year and a prevalence of 115 / 100,000 inhabitants per year. The causes of uveitis are numerous and include infectious diseases, systemic and neurological diseases, ophthalmic entities, neoplasia, and drug-related reactions. The etiological diagnosis is important both for prognosis and therapeutics. However, clinical evaluations to establish etiological diagnosis are not standardized. Some authors suggest a minimalist examination, common to all kinds of uveitis. On the other hand, others propose an evaluation guided by the anatomo-clinical type of uveitis. We conducted a retrospective study to assess the contribution of complementary examinations to etiological determination. In this study, we found that most patients benefited from a wide paraclinical evaluation compared to what is usually described in the literature. Complementary examinations were mostly systematic, without any clinical or ophthalmological elements of orientation. This study highlighted the lack of contribution of some examinations. Using these results, and the literature analysis, we designed a diagnostic algorithm adapted to the anatomo-clinical type of uveitis. Moreover, we found that the average cost per patient was estimated at €290.51 with the algorithm compared to €560.83 without it. We would like to carry out a new study to estimate the efficiency as well as the medico-economic impact of the use of a standardized strategy for the etiological diagnosis of uveitis, compared with a free strategy. Hypothesis:

• The standardized strategy for the diagnostic of uveitis is at least as efficient as the free one, and costs half as much.
• The examinations prescribed, except for those from the standardized strategy, do not contribute to etiological determination.

Conditions

Uveitis

Keywords

Uveitis; etiological diagnosis; standardized strategy

Outcome Measures

Primary Outcomes (1)

• The primary outcome is the percentage of patients having an etiological diagnosis 6 months after the beginning of the study for both strategies.

  Note: Only diagnoses made at the end of the standardized strategy will be numbered in this arm of the study; all diagnoses made after by the free authorized examinations in this same arm will lead to standardized strategy failure.

  6 months

Secondary Outcomes (4)

• Clinical criteria concerning the standardized strategy

  6 months

• Clinical criteria concerning the free strategy

  6 months

• The average cost of economic criteria for each strategy.

  12 months

• Quality of life criteria

  : 6 months

Study Arms (2)

Free strategy

ACTIVE COMPARATOR

Free strategy followed in order to make the etiological diagnosis, which means, investigators are free to perform any examination they thought necessary.

Other: Free strategy

Experimental strategy

EXPERIMENTAL

Etiological diagnosis made by following a standardized two-stage strategy: first-line assessment (listed examinations and then examinations directed by the clinical or para-clinical elements of orientation) and second or third-line assessment (examinations directed by the anatomo-clinical type of uveitis).

Other: Standardized strategy

Interventions

Free strategy OTHER

Free strategy followed in order to make the etiological diagnosis, which means, investigators are free to perform any examination they thought necessary.

Also known as: Procedure or strategy leading to the etiological diagnosis of the uveitis.

Free strategy

Standardized strategy OTHER

Etiological diagnosis made by following a standardized two-stage strategy: first-line assessment (listed examinations and then examinations directed by the clinical or para-clinical elements of orientation) and second or third-line assessment (examinations directed by the anatomo-clinical type of uveitis).

Experimental strategy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Uveitis
• Patient consulting one of the study's sites
• Age \> 18 years old
• Affiliation to the French national health insurance program
• Patient agreeing to participate in the study

You may not qualify if:

• Positive HIV serology
• Postsurgical or posttraumatic uveitis or endophthalmitis
• Toxoplasmic uveitis
• Pathology likely to be the cause of the known uveitis
• Ophthalmic entities only diagnosed by the ophthalmic examination
• Age \< 18 years old
• Patient under law protection or guardianship
• Pregnant women or those planning to be pregnant during the study
• Severe uveitis (VA \< 20/200) with retinal vascularitis requiring an emergency treatment and assessment.

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

Service de Médecine Interne, Hospices Civils de Lyon (HCL)-Hôpital de la Croix Rousse

Lyon, 69004, France

Location

Related Publications (1)

• de Parisot A, Kodjikian L, Errera MH, Sedira N, Heron E, Perard L, Cornut PL, Schneider C, Riviere S, Olle P, Pugnet G, Cathebras P, Manoli P, Bodaghi B, Saadoun D, Baillif S, Tieulie N, Andre M, Chiambaretta F, Bonin N, Bielefeld P, Bron A, Mouriaux F, Bienvenu B, Vicente S, Bin S, Broussolle C, Decullier E, Seve P; ULISSE group. Randomized Controlled Trial Evaluating a Standardized Strategy for Uveitis Etiologic Diagnosis (ULISSE). Am J Ophthalmol. 2017 Jun;178:176-185. doi: 10.1016/j.ajo.2017.03.029. Epub 2017 Mar 31.

  PMID: 28366648 BACKGROUND

MeSH Terms

Conditions

Uveitis

Interventions

Bloodless Medical and Surgical Procedures

Condition Hierarchy (Ancestors)

Uveal Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Patient Care; Therapeutics; Surgical Procedures, Operative; Health Services; Health Care Facilities Workforce and Services

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 12, 2010
• First Posted: July 14, 2010
• Study Start: June 1, 2010
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2014
• Last Updated: September 4, 2025

Record last verified: 2025-08

Locations

FR (1)