A Decision Aid for Patients With Age-related Cataract

Sun Yat-sen University

Status: Unknown

Conditions: Age-related Cataract

Treatments: Other: A patient decision aid; Other: A usual education booklet

Study type: Interventional

Funder types: Other

Identifiers

NCT03992807

2019KYPJ090

Details and patient eligibility

About

To determine whether a decision aid increases informed decision about cataract surgery for patients with age-related cataract.

Full description

The need for cataract surgery is on the rise globally due to the aging population and high demands for greater visual functioning. Patients with age-related cataract face their initial decision about when to undergo cataract surgery. Although the majority of patients want to participate in a shared decision-making process, no decision aid has been available to improve the quality of decision. The purpose of this study is to determine whether a decision aid increases informed decision about cataract surgery for patients with age-related cataract.

Enrollment: 773 patients

Sex: All

Ages: 50 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

1. Individuals aged 50-80 years who have been resident in the selected study district for more than six months;
2. A definite diagnosis of age-related cataract;
3. Having not received cataract surgery;
4. Willing to participate in the study and provide informed content.

Exclusion criteria

1. Bilateral blindness (presenting distance visual acuity worse than 3/60);
2. Having ocular, hearing or mental disorder precluding reading or telephone interview;
3. Ocular disorders other than cataract leading to permanent vision loss that could not be corrected through cataract surgery;
4. Having cataract surgery contraindication.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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773 participants in 2 patient groups

A patient decision aid

Experimental group

Description:

A patient decision aid that includes not only the standard general information, but also the quantitative risk information on the possible outcomes of cataract surgery as well as value clarification exercise.

Treatment:

Other: A patient decision aid

A usual education booklet

Active Comparator group

Description:

A traditional booklet with standard general information developed by the National Eye Institute (NEI) to help patients understand cataract.

Treatment:

Other: A usual education booklet