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

A qualitative and quantitative study of the factors that influences the prosthetics rehabilitation of anophtalmic patients.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-8vzwdg
Enrollment
Unknown
Registered
2018-09-24
Start date
2017-07-25
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Psychological stress

Interventions

The study will be divided into two parts: Part 1 - Twenty individuals who are not users of ocular prosthesis will be evaluated for the motivation to seek treatment for their disability through a quali
quality of life, through the SF-36 questionnaires
and stress perception through the PSS-10 questionnaires. Quality of life and stress will be evaluated before and after 03 and 06 months of the installation of ocular prostheses. The difficulties of ad
Protocol 2 (Pt2): Cleaning the ocular prosthesis with neutral soap (neutral pH, odorless) once a week and use of sal
Other
E07.695.225

Sponsors

Faculdade de Odontologia de Ribeirão Preto da Universidade de São Paulo
Lead Sponsor
Faculdade de Odontologia de Ribeirão Preto da Universidade de São Paulo
Collaborator

Eligibility

Age
18 Years to No maximum

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
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; ;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

MeasureTime frame
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. ;Part 2: Evaluation of hygiene protocols by users through a structured questionnaire.

Countries

Brazil

Contacts

Public ContactLaís Ranieri Makrakis

Faculdade de Odontologia de Ribeirão Preto da Universidade de São Paulo

lais.makrakis@usp.br+55-16-33154800

Outcome results

None listed

Source: REBEC (via WHO ICTRP)