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Effectiveness of Training in Reading Rehabilitation for Patients With Diabetic Macular Oedema

Effectiveness of Training in Reading Rehabilitation for Patients With Diabetic Macular Oedema (DMO)- Randomized Controlled Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02457884
Enrollment
55
Registered
2015-05-29
Start date
2015-05-31
Completion date
2018-06-30
Last updated
2019-02-25

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

Conditions

Diabetic Macular Oedema, Parafoveal Scotoma

Keywords

Diabetic macular oedema, Perceptual learning, Chinese, Hong Kong

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.

Detailed description

Patients with diabetic macular oedema (DMO), after receiving laser photocoagulation, achieved good outcomes in distance acuity. However, some patients, particularly those developing parafoveal scotoma, still had difficulty in reading. Inability to read or reading very slowly leads to the potential loss of job, as well as the enjoyment of reading for leisure. In this study, the investigators aimed to investigate the effectiveness of reading rehabilitation using perceptual learning paradigms in enhancing reading performance in patients with reading difficulties due to DMO. Also, the fundamental mechanisms explaining the reading problems in patients with DMO reading Chinese will be examined. The investigators hypothesize that the perceptual training would show an improvement in reading. The investigators' primary hypothesis is that temporal visual processing speed and spatial visual span will be improved after perceptual training. The investigators' secondary hypothesis is that the reading speed and fixation stability will be improved after training.

Interventions

OTHERTemporal Group

Visual Processing Training

OTHERSpatial Group

Spatial visual span training

Visual processing speed and spatial visual span training

OTHERControl Group

Leisure reading activities

Sponsors

The University of Hong Kong
CollaboratorOTHER
The Hong Kong Polytechnic University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
21 Years to 70 Years
Healthy volunteers
No

Inclusion criteria

* 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)

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Change in visual processing speedChange from baseline at week 6 and change from baseline at week 12 weekUsing trigrams to measure the character-recognition accuracy while characters are presented at different exposure times
Change in visual span sizeChange from baseline at week 6 and change from baseline at week 12 weekUsing trigrams to measure the character-recognition accuracy while characters are presented at different positions

Secondary

MeasureTime frameDescription
Change in reading performanceChange from baseline at week 6 and change from baseline at week 12 weekMeasured in three different ways for Chinese: 1. Rapid serial visual presentation (RSVP) 2. Sentence reading (MNREAD) 3. Passage reading (IReST)
Change in fixation stabilityChange from baseline at week 6 and change from baseline at week 12 weekFixation stability will be measured by MP-1 microperimeter.
Change in Chinese version of Impact of Visually Impaired (C-IVI) measureChange from baseline at week 6 and change from baseline at week 12 weekSelf evaluated instrument to measure vision related restriction of participation in daily living.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026