--- title: Impact of a Printed Decision Aid on Cataract Surgery Choice nct_id: NCT03525015 overall_status: UNKNOWN phase: NA sponsor: Sun Yat-sen University study_type: INTERVENTIONAL primary_condition: Age Related Cataracts countries: China canonical_url: "https://parkinsonspathways.com/agent/trials/NCT03525015.md" clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT03525015" ct_last_update_post_date: 2018-12-26 last_seen_at: "2026-05-12T06:47:06.285Z" source: ClinicalTrials.gov (mirrored, no enrichment) --- # Impact of a Printed Decision Aid on Cataract Surgery Choice **Official Title:** Impact of a Printed Decision Aid on Cataract Surgery Choice: A Multi-center Randomized Controlled Trial **NCT ID:** [NCT03525015](https://clinicaltrials.gov/study/NCT03525015) ## Key Facts - **Status:** UNKNOWN - **Phase:** NA - **Study Type:** INTERVENTIONAL - **Target Enrollment:** 696 - **Lead Sponsor:** Sun Yat-sen University - **Conditions:** Age Related Cataracts - **Start Date:** 2018-05-16 - **Completion Date:** 2019-10-30 - **CT.gov Last Update:** 2018-12-26 ## Brief Summary The purpose of the study is to explore whether a decision aid booklet is more effective than the usual booklet for patients to make an informed choice on cataract surgery. ## Detailed Description Shared decision making is increasingly recommended to facilitate quality care, but there is a lack of cataract surgery decision aid in clinical practice. The aim of this study is to evaluate the effectiveness of a cataract surgery decision aid for cataract patients with different levels of health literacy. We will conduct a randomized controlled trial for cataract patients aged 50-80 years. We will randomly assign participants to either the intervention using a decision aid booklet or the one using a usual cataract booklet. The primary outcome is informed choice (defined as adequate knowledge and consistency between attitudes and intentions) 2 weeks after intervention. ## Eligibility - **Minimum age:** 50 Years - **Maximum age:** 80 Years - **Sex:** ALL - **Healthy Volunteers:** No ``` Inclusion Criteria: 1. Definite diagnosis of age-related cataract; 2. The best corrected visual acuity (BCVA) is above 20/60; 3. Cataract opacity meets any of the following criterion based on lens opacity classification system (LOCS) III: nuclear color and nuclear opalescence is greater than or equal to grade 2 (NO2/NC2); cortical opacity is greater than or equal to grade 2 (C2); posterior subcapsular opacity is greater than or equal to grade 2 (P2); 4. Willing to know about cataract and cataract surgery; 5. Being able to afford cataract surgery; 6. Willing to participate in the study and provide the informed content. Exclusion Criteria: 1. Having received cataract surgery; 2. Having hearing disorders; 3. Having mental disorders; 4. Having ocular disorders other than cataract; 5. Having surgery contraindication; 6. Unwilling to participate in this study. ``` ## Arms - **A decision aid booklet** (EXPERIMENTAL) — A decision aid booklet about cataract surgery choice - **An usual booklet** (ACTIVE_COMPARATOR) — An usual booklet about cataract and cataract surgery ## Interventions - **A decision aid booklet about cataract surgery choice** (OTHER) — Potential participants receive a decision aid booklet with information about cataract surgery choice, and outcome data will be gathered using standardized questions in a structured interview after 2 weeks and 1 year. - **An usual booklet about cataract and cataract surgery** (OTHER) — Potential participants receive an usual booklet with information about cataract and cataract surgery, and outcome data will be gathered using standardized questions in a structured interview after 2 weeks and 1 year. ## Primary Outcomes - **Informed choice about cataract surgery** _(time frame: 2 weeks)_ — Informed choice is measured as the proportion of participants who make an informed choice about whether to receive cataract surgery as soon as possible or not. For the individual, making an informed choice is defined as (i) having adequate knowledge and (ii) expressing intentions that are consistent with （iii）one's attitudes. Knowledge will be measured by assessing participants' understanding of the numerical and conceptual information in the booklets, using items modified from previous screening decision aid trials (Hersch 2015). Attitudes towards cataract surgery will be assessed using a theory-based generic screening attitudes scale (Dormandy 2006). A single item will measure intentions about having cataract surgery as soon as possible (or not), using a set of 5 response options (Gwyn 2003; Watson 2006). ## Secondary Outcomes - **Perceived importance of cataract surgery benefit/harms** _(time frame: 2 weeks)_ - **Perceived personal chances of surgical benefit/harms** _(time frame: 2 weeks)_ - **Decisional conflict** _(time frame: 2 weeks)_ - **Decisional confidence** _(time frame: 2 weeks)_ - **Time perspective** _(time frame: 2 weeks)_ - **Anticipated regret** _(time frame: 2 weeks)_ - **Cataract worry and anxiety** _(time frame: 2 weeks)_ - **Booklet utilization and acceptability** _(time frame: 2 weeks)_ - **Undergoing cataract surgery** _(time frame: 1 year)_ - **Decision regret** _(time frame: 1 year)_ ## Locations (11) - Dashi Community Health Center, Guangzhou, China — _RECRUITING_ - Donghuan Community Health Center, Guangzhou, China — _RECRUITING_ - Huangcun Community Health Center, Guangzhou, China — _RECRUITING_ - Huaying Community Health Center, Guangzhou, China — _RECRUITING_ - Qiaonan Community Health Center, Guangzhou, China — _RECRUITING_ - Shawan Community Health Center, Guangzhou, China — _RECRUITING_ - Shibi Community Health Center, Guangzhou, China — _RECRUITING_ - Shiqiao Community Health Center, Guangzhou, China — _RECRUITING_ - Xiayuan Community Health Center, Guangzhou, China — _RECRUITING_ - Yuancun Community Health Center, Guangzhou, China — _RECRUITING_ - Zhognshan Ophthalmic Center, Sun Yat-sen University, Guangzhou, China — _RECRUITING_ ## Recent Field Changes (last 30 days) - `eligibility.maxAge` — added _(2026-05-12)_ - `eligibility.sex` — added _(2026-05-12)_ - `status.completionDate` — added _(2026-05-12)_ - `status.lastUpdatePostDate` — added _(2026-05-12)_ - `design.phases` — added _(2026-05-12)_ - `design.enrollmentCount` — added _(2026-05-12)_ - `locations.shiqiao community health center|guangzhou||china` — added _(2026-05-12)_ - `eligibility.criteria` — added _(2026-05-12)_ - `eligibility.minAge` — added _(2026-05-12)_ - `status.overallStatus` — added _(2026-05-12)_ - `status.primaryCompletionDate` — added _(2026-05-12)_ - `outcomes.primary` — added _(2026-05-12)_ - `outcomes.secondary` — added _(2026-05-12)_ - `armsInterventions.arms` — added _(2026-05-12)_ - `armsInterventions.interventions` — added _(2026-05-12)_ - `sponsor.lead` — added _(2026-05-12)_ - `results.hasResults` — added _(2026-05-12)_ - `locations.dashi community health center|guangzhou||china` — added _(2026-05-12)_ - `locations.donghuan community health center|guangzhou||china` — added _(2026-05-12)_ - `locations.huangcun community health center|guangzhou||china` — added _(2026-05-12)_ - `locations.huaying community health center|guangzhou||china` — added _(2026-05-12)_ - `locations.qiaonan community health center|guangzhou||china` — added _(2026-05-12)_ - `locations.shawan community health center|guangzhou||china` — added _(2026-05-12)_ - `locations.shibi community health center|guangzhou||china` — added _(2026-05-12)_ - `locations.xiayuan community health center|guangzhou||china` — added _(2026-05-12)_ - `locations.yuancun community health center|guangzhou||china` — added _(2026-05-12)_ - `locations.zhognshan ophthalmic center, sun yat-sen university|guangzhou||china` — added _(2026-05-12)_ --- *Canonical: https://parkinsonspathways.com/agent/trials/NCT03525015.md* *Source data (authoritative): https://clinicaltrials.gov/study/NCT03525015* *This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*