NCT02457884

Brief Summary

Diabetic macular oedema (DMO) is a sight-threatening problem for diabetic patient who has swelling in macula. Patients with DMO can receive laser treatment and achieve good acuity finally. However, some patients still have difficulties in reading even after proper treatment. In this project, the investigators aimed to explore the effectiveness of different training paradigms in improving reading performance in patients with DMO.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
55

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2015

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

May 25, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 29, 2015

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2018

Completed
Last Updated

February 25, 2019

Status Verified

February 1, 2019

Enrollment Period

2.8 years

First QC Date

May 25, 2015

Last Update Submit

February 21, 2019

Conditions

Diabetic Macular OedemaParafoveal Scotoma

Keywords

Diabetic macular oedemaPerceptual learningChineseHong Kong

Outcome Measures

Primary Outcomes (2)

  • Change in visual processing speed

    Using trigrams to measure the character-recognition accuracy while characters are presented at different exposure times

    Change from baseline at week 6 and change from baseline at week 12 week

  • Change in visual span size

    Using trigrams to measure the character-recognition accuracy while characters are presented at different positions

    Change from baseline at week 6 and change from baseline at week 12 week

Secondary Outcomes (3)

  • Change in reading performance

    Change from baseline at week 6 and change from baseline at week 12 week

  • Change in fixation stability

    Change from baseline at week 6 and change from baseline at week 12 week

  • Change in Chinese version of Impact of Visually Impaired (C-IVI) measure

    Change from baseline at week 6 and change from baseline at week 12 week

Study Arms (4)

Temporal Group

ACTIVE COMPARATOR

Receive 6 weekly 1-hour training sessions by Trigrams (A tailor made reading-task training programme).

Other: Temporal Group

Spatial Group

ACTIVE COMPARATOR

Receive 6 weekly 1-hour training sessions by Trigrams (A tailor made reading-task training programme).

Other: Spatial Group

Combined Group

ACTIVE COMPARATOR

Receive 6 weekly 1-hour training sessions by Trigrams (A tailor made reading-task training programme).

Other: Combined Group

Control Group

PLACEBO COMPARATOR

Receive 6 weekly 1-hour training sessions of leisure reading activities

Other: Control Group

Interventions

Temporal GroupOTHER

Visual Processing Training

Temporal Group
Spatial GroupOTHER

Spatial visual span training

Spatial Group
Combined GroupOTHER

Visual processing speed and spatial visual span training

Combined Group
Control GroupOTHER

Leisure reading activities

Control Group

Eligibility Criteria

Age21 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Able to read Chinese.
  • No formal vision rehabilitation training in reading after vision loss
  • Diagnosis of diabetic macular oedema (DMO) and had previous treatment with laser and / or intravitreal injections
  • Reasonable control of blood glucose level (HbA1c \<10) to minimize the impact of vision fluctuation
  • Education level of 6 years or more (primary school or above)

You may not qualify if:

  • Receive any types of eye treatments other than those mentioned above
  • Any diagnosed ocular diseases other than DMO
  • Severe medical problems or self reported neurological or cognitive disorders
  • Serious hearing impairment
  • Previously attended vision rehabilitation clinic

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Allen MY Cheong

Hong Kong, China

Location

MeSH Terms

Interventions

Control Groups

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • Allen Ming Yan Cheong, PhD

    The Hong Kong Polytechnic University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

May 25, 2015

First Posted

May 29, 2015

Study Start

May 1, 2015

Primary Completion

March 1, 2018

Study Completion

June 1, 2018

Last Updated

February 25, 2019

Record last verified: 2019-02

Locations

CN(1)