Study of the factors that influence the treatment of blind individuals with ocular prosthesis.

Not Applicable

• Conditions: Psychological stress; quality of life; protocols.; F01.145.126.990; I01.800; SP4.011.127.433.849

• Registration Number: RBR-8vzwdg
• Lead Sponsor: Faculdade de Odontologia de Ribeirão Preto da Universidade de São Paulo

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-09-24
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Recruitment completed
• Sex: Not specified
• Target Recruitment: Not specified

Inclusion Criteria

Part 1: adult subjects. both sexes; non-users of ocular prosthesis; good general health; understand the Portuguese language; anophthalmic cavity with space. Part 2: adult individuals; both sexes; users of ocular prosthesis; good general health; understand the Portuguese language.

Exclusion Criteria

Part 1: local inflammatory or infectious disease; neoplasms or other deformities not previously treated; presence of oculo-palpebral prosthesis; alcoholism; serious diseases; preconceived cognitive function; impossibility of attending to the returns. Part 2: local inflammatory or infectious disease; neoplasms or other deformities not previously treated; presence of eye-palpebral prosthesis; Use of antibiotic and/or topical or systemic corticosteroids in the last 3 months; alcoholism; serious diseases; preconceived cognitive function; impossibility of attending to the returns.

Study & Design

• Study Type: Intervention
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Part 1: Identifying the motivating factors for seeking treatment through a semi-structured questionnaire; to evaluate the quality of life and stress through the SF-36 and PSS-10 questionnaires, respectively;<br>;Part 2: Evaluate the effect of hygiene protocols on the health of tissues of the anophthalmic cavity and reduction of the microbial load by counting the UFC.

Secondary Outcome Measures

Name	Time	Method
Part 1: To evaluate the difficulties of adaptation with the ocular prosthesis and its relation with the sociodemographic characteristics, cause of the indication, type of surgery performed and time between surgery and prosthetic rehabilitation through a structured questionnaire.<br>;Part 2: Evaluation of hygiene protocols by users through a structured questionnaire.