Trial Outcomes & Findings for Guangdong Uptake of Surgery Trial (NCT NCT01123928)

Results Overview

Measured as a percentage of subjects who decide to undergo cataract surgery within 6 months after screening (positive) out of total subjects.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

434 participants

Primary outcome timeframe

within 6 months after screening examination

Results posted on

2012-02-03

Subjects were recruited from 32 outreach screening sessions in various villages and townships of Guangdong province from June 2010 to November 2010.

Participant milestones
Measure	Counseling Subjects will be asked to watch a 5-10 min video and participate in a 10-15 min pre-operative counseling session with a trained nurse. Subjects will also participate in a 5 min post-operative counseling session.	Non-counseling Subjects will be told that they had decreased vision due to cataract and that this could be treated, without being shown the video or given the counseling session by the nurse.
Overall Study STARTED	212	222
Overall Study COMPLETED	212	222
Overall Study NOT COMPLETED	0	0

Withdrawal data not reported

Guangdong Uptake of Surgery Trial

Baseline characteristics by cohort
Measure	Counseling n=212 Participants Subjects will be asked to watch a 5-10 min video and participate in a 10-15 min pre-operative counseling session with a trained nurse. Subjects will also participate in a 5 min post-operative counseling session.	Non-counseling n=222 Participants Subjects will be told that they had decreased vision due to cataract and that this could be treated, without being shown the video or given the counseling session by the nurse.	Total n=434 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	29 Participants n=5 Participants	19 Participants n=7 Participants	48 Participants n=5 Participants
Age, Categorical >=65 years	183 Participants n=5 Participants	203 Participants n=7 Participants	386 Participants n=5 Participants
Age Continuous	73.4 years STANDARD_DEVIATION 8.7 • n=5 Participants	75.5 years STANDARD_DEVIATION 8.0 • n=7 Participants	74.5 years STANDARD_DEVIATION 8.4 • n=5 Participants
Sex: Female, Male Female	128 Participants n=5 Participants	121 Participants n=7 Participants	249 Participants n=5 Participants
Sex: Female, Male Male	84 Participants n=5 Participants	101 Participants n=7 Participants	185 Participants n=5 Participants
Region of Enrollment China	212 participants n=5 Participants	222 participants n=7 Participants	434 participants n=5 Participants

Timeframe: within 6 months after screening examination

Population: All participants who completed the study were analyzed.

Measured as a percentage of subjects who decide to undergo cataract surgery within 6 months after screening (positive) out of total subjects.

Outcome measures
Measure	Counseling n=212 Participants Subjects will be asked to watch a 5-10 min video and participate in a 10-15 min pre-operative counseling session with a trained nurse. Subjects will also participate in a 5 min post-operative counseling session.	Non-counseling n=222 Participants Subjects will be told that they had decreased vision due to cataract and that this could be treated, without being shown the video or given the counseling session by the nurse.
Decision to Undergo Cataract Surgery (Surgery Acceptance)	31.1 percentage of participants	34.2 percentage of participants

Timeframe: within 6 months after screening examination

Population: All participants who completed the study were analyzed.

Measured as a percentage of people who presented to the hospital within 6 months after screening (positive) out of total subjects.