Diabetic Macular OedemaNCT02457884
Effectiveness of Training in Reading Rehabilitation for Patients With Diabetic Macular Oedema
A study testing Temporal Group, Spatial Group and Combined Group in people with Diabetic Macular Oedema and Parafoveal Scotoma, run by The Hong Kong Polytechnic University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 70 years
- Conditions the study is for
- Diabetic Macular Oedema, Parafoveal Scotoma
- What is being tested?
- Temporal Group, Spatial Group and Combined Group
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 55 participants
- Where
- 1 siteChina
- Study dates
- May 2015to Jun 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Training in Reading Rehabilitation for Patients With Diabetic Macular Oedema (DMO)- Randomized Controlled Trial
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.
Read the 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.
- Conditions
- Diabetic Macular Oedema, Parafoveal Scotoma
- Being tested
- Temporal Group, Spatial Group, Combined Group, Control Group
- Keywords
- Diabetic macular oedema, Perceptual learning, Chinese, Hong Kong
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Temporal GroupOther
Visual Processing Training
Spatial GroupOther
Spatial visual span training
Combined GroupOther
Visual processing speed and spatial visual span training
Control GroupOther
Leisure reading activities
| Study group | Role | What they receive |
|---|---|---|
| Temporal Group | Active comparator | Receive 6 weekly 1-hour training sessions by Trigrams (A tailor made reading-task training programme). Receives: Other: Temporal Group |
| Spatial Group | Active comparator | Receive 6 weekly 1-hour training sessions by Trigrams (A tailor made reading-task training programme). Receives: Other: Spatial Group |
| Combined Group | Active comparator | Receive 6 weekly 1-hour training sessions by Trigrams (A tailor made reading-task training programme). Receives: Other: Combined Group |
| Control Group | Placebo comparator | Receive 6 weekly 1-hour training sessions of leisure reading activities Receives: Other: Control Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in visual processing speed
Using trigrams to measure the character-recognition accuracy while characters are presented at different exposure times
Measured: 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
Measured: Change from baseline at week 6 and change from baseline at week 12 week
Secondary outcomes (3)
Change in reading performance
Measured in three different ways for Chinese:
- Rapid serial visual presentation (RSVP)
- Sentence reading (MNREAD)
- Passage reading (IReST)
Measured: Change from baseline at week 6 and change from baseline at week 12 week
Change in fixation stability
Fixation stability will be measured by MP-1 microperimeter.
Measured: 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
Self evaluated instrument to measure vision related restriction of participation in daily living.
Measured: Change from baseline at week 6 and change from baseline at week 12 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2015 (estimated)
- Study startMay 2015
- Primary completionMar 2018
- Study completionJun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Macular OedemaStudies of the same condition, open and under way.
- More trials run by The Hong Kong Polytechnic UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Collaborators
- The University of Hong Kong
- Responsible party
- Principal investigator, Allen MY Cheong, The Hong Kong Polytechnic University
- Investigators
- Allen Ming Yan Cheong, PhD, Principal investigator, The Hong Kong Polytechnic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02457884
- Sponsor's protocol ID
- 12131601
- Status last verified
- Feb 2019
- First submitted
- 25 May 2015
- Last updated
- 25 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Training in Reading Rehabilitation for Patients With Diabetic Macular Oedema (DMO)- Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02457884
- Acronym / sponsor ID
- 12131601
- Conditions
- Diabetic Macular Oedema, Parafoveal Scotoma
- Keywords
- Diabetic macular oedema, Perceptual learning, Chinese, Hong Kong
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Collaborators
- The University of Hong Kong
- Study start
- May 2015 (actual)
- Primary completion
- Mar 2018 (actual)
- Study completion
- Jun 2018 (actual)
- First posted
- 29 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Temporal Group | Active comparator | Other: Temporal GroupReceive 6 weekly 1-hour training sessions by Trigrams (A tailor made reading-task training programme). |
| Spatial Group | Active comparator | Other: Spatial GroupReceive 6 weekly 1-hour training sessions by Trigrams (A tailor made reading-task training programme). |
| Combined Group | Active comparator | Other: Combined GroupReceive 6 weekly 1-hour training sessions by Trigrams (A tailor made reading-task training programme). |
| Control Group | Placebo comparator | Other: Control GroupReceive 6 weekly 1-hour training sessions of leisure reading activities |
Who may qualify
- Ages
- 21 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Temporal GroupVisual Processing Training | Other | Temporal Group |
| Spatial GroupSpatial visual span training | Other | Spatial Group |
| Combined GroupVisual processing speed and spatial visual span training | Other | Combined Group |
| Control GroupLeisure reading activities | Other | Control Group |
Primary outcome
Change in visual processing speed
Time frame: Change from baseline at week 6 and change from baseline at week 12 week
Using trigrams to measure the character-recognition accuracy while characters are presented at different exposure times
Change in visual span size
Time frame: Change from baseline at week 6 and change from baseline at week 12 week
Using trigrams to measure the character-recognition accuracy while characters are presented at different positions
3 secondary outcomes
Change in reading performance
Time frame: Change from baseline at week 6 and change from baseline at week 12 week
Change in fixation stability
Time frame: 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
Time frame: Change from baseline at week 6 and change from baseline at week 12 week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Allen Ming Yan Cheong, PhD principal investigator
The Hong Kong Polytechnic University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Temporal Group, Spatial Group and Combined Group in people with Diabetic Macular Oedema and Parafoveal Scotoma, run by The Hong Kong Polytechnic University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in visual processing speed (time frame: Change from baseline at week 6 and change from baseline at week 12 week). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2019.