Diabetic Retinopathy, Macula Edema
Conditions
Keywords
micro-pulse laser, trans-foveal
Brief summary
Anti-vascular endothelial growth factor (VEGF) therapy is currently the mainstay of treatment for diabetic macular edema (DME). One of the main obstacles of anti-VEGF therapy is the need of repeated injections, which carries both economic and compliance problems to the patients.there is a growing evidence that recognises the effectiveness of the use of micropulse laser (MPL) in treatment of DME. with MPL, it is possible to deliver a subthreshold laser that is above the threshold of biochemical effect but below the threshold of a visible, destructive lesion thereby preventing collateral damage.The MPL technique is available at near - infrared 810 nm diode laser (diode MPL) and at 577 nm (yellow MPL). The current study was conducted in order to compare the efficacy of both MPL techniques in the treatment of center involving DME.
Detailed description
This was a prospective randomized comparative study that included 30 eyes of 15 patients with bilateral DME. The patients were recruited from the Retina Clinic at Kasr Al Ainy Hospital, Cairo University. The study's protocol was reviewed and approved by board of the ophthalmology department, Cairo University, and was in concordance with the tents of Declaration of Helsinki. Eligible patients were informed about the study's objectives, methodology, risks and benefits. A written informed consent was obtained from every patient included in this study.Preliminary examination was in the form of slit-lamp examination, fundus examination, intra ocular pressure measurement, and best corrected visual acuity (BCVA) measurement. A spectral domain optical coherence tomogram (OCT) scan was performed to all patients before treatment to measure the central retinal thickness (CRT). The eyes were randomized into two groups; one eye (right eye) of each patient was treated with 577-nm yellow MPL and the other eye (left eye) of the same patient with Infrared 810-nm diode MPL. Changes in the BCVA and CRT were measured after treatment at 1 and 3 months of follow up.
Interventions
DEVICEYellow micro-pulse laser
applying 577-nm yellow laser in a micro-pulse mode over the macular area including the fovea
DEVICEDiode micro-pulse laser
applying 810-nm infra-red diode laser in a micro-pulse mode over the macular area including the fovea
Sponsors
Cairo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* bilateral diabetic macular edema * center involving confirmed by Optical coherence tomogram (OCT)
Exclusion criteria
* any non-diabetic macular edema * significant media opacities * previous laser treatment, any intraocular surgery within the past 6 months * previous intravitreal injections of any drug within the past 6 months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Central Retinal Thickness (CRT) | baseline, at 1 month and 3 months after the intervention | detecting changes in the thickness of the center of the macula |
| Change in the Best Corrected Visual Acuity (BCVA) | baseline, at 1 month and 3 months after the intervention | detecting changes in the the best corrected visual acuity in logMAR. A LogMAR chart comprises rows of letters and is used by ophthalmologists, optometrists and vision scientists to estimate visual acuity. This chart was developed at the National Vision Research Institute of Australia in 1976, and is designed to enable a more accurate estimate of acuity than do other charts (e.g., the Snellen chart). For this reason, the LogMAR chart is recommended, particularly in a research setting. A Snellen score of 6/6 (20/20), indicating that an observer can resolve details as small as 1 minute of visual angle, corresponds to a LogMAR of 0 (since the base-10 logarithm of 1 is 0); a Snellen score of 6/12 (20/40), indicating an observer can resolve details as small as 2 minutes of visual angle, corresponds to a LogMAR of 0.3 (since the base-10 logarithm of 2 is near-approximately 0.3), and so on.Therefore, a higher logMAR scores mean a worse outcome. |
Countries
Egypt
Participant flow
Recruitment details
one eye (Right) from each patient was assigned to one arm (yellow MPL) and the other eye (Left) of the same patient to the 2nd arm (diode MPL). Therefore, the total number of enrolled participants was 15 contributing to total of 30 eyes (units) i.e there were 15 participants contributing to 15 eyes in each arm of the study.
Participants by arm
| Arm | Count |
|---|---|
| Yellow MPL Yellow micro-pulse laser: applying 577-nm yellow laser in a micro-pulse mode over the macular area including the fovea | 13 |
| Diode MPL Diode micro-pulse laser: applying 810-nm infra-red diode laser in a micro-pulse mode over the macular area including the fovea | 13 |
| Total | 26 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lack of Efficacy | 2 | 2 |
Baseline characteristics
| Characteristic | Diode MPL | Total | Yellow MPL |
|---|---|---|---|
| Age, Continuous | 58.23 years STANDARD_DEVIATION 8.03 | 58.23 years STANDARD_DEVIATION 8.03 | 58.23 years STANDARD_DEVIATION 8.03 |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment Egypt | 13 participants | 13 participants | 13 participants |
| Sex: Female, Male Female | 5 Participants | 10 Participants | 5 Participants |
| Sex: Female, Male Male | 8 Participants | 16 Participants | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 15 | 0 / 15 |
| other Total, other adverse events | 0 / 15 | 0 / 15 |
| serious Total, serious adverse events | 0 / 15 | 0 / 15 |
Outcome results
Primary
Change in Central Retinal Thickness (CRT)
detecting changes in the thickness of the center of the macula
Time frame: baseline, at 1 month and 3 months after the intervention
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Yellow MPL | Change in Central Retinal Thickness (CRT) | Baseline | 384.62 micrometer | Standard Deviation 147.06 |
| Yellow MPL | Change in Central Retinal Thickness (CRT) | 1 month | 349.15 micrometer | Standard Deviation 141.78 |
| Yellow MPL | Change in Central Retinal Thickness (CRT) | 3 months | 321.92 micrometer | Standard Deviation 126.65 |
| Diode MPL | Change in Central Retinal Thickness (CRT) | Baseline | 374 micrometer | Standard Deviation 130.42 |
| Diode MPL | Change in Central Retinal Thickness (CRT) | 1 month | 357.62 micrometer | Standard Deviation 116.23 |
| Diode MPL | Change in Central Retinal Thickness (CRT) | 3 months | 339.69 micrometer | Standard Deviation 111.94 |
Primary
Change in the Best Corrected Visual Acuity (BCVA)
detecting changes in the the best corrected visual acuity in logMAR. A LogMAR chart comprises rows of letters and is used by ophthalmologists, optometrists and vision scientists to estimate visual acuity. This chart was developed at the National Vision Research Institute of Australia in 1976, and is designed to enable a more accurate estimate of acuity than do other charts (e.g., the Snellen chart). For this reason, the LogMAR chart is recommended, particularly in a research setting. A Snellen score of 6/6 (20/20), indicating that an observer can resolve details as small as 1 minute of visual angle, corresponds to a LogMAR of 0 (since the base-10 logarithm of 1 is 0); a Snellen score of 6/12 (20/40), indicating an observer can resolve details as small as 2 minutes of visual angle, corresponds to a LogMAR of 0.3 (since the base-10 logarithm of 2 is near-approximately 0.3), and so on.Therefore, a higher logMAR scores mean a worse outcome.
Time frame: baseline, at 1 month and 3 months after the intervention
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Yellow MPL | Change in the Best Corrected Visual Acuity (BCVA) | Baseline | 0.68 logMar | Standard Deviation 0.3 |
| Yellow MPL | Change in the Best Corrected Visual Acuity (BCVA) | 1 month | 0.60 logMar | Standard Deviation 0.33 |
| Yellow MPL | Change in the Best Corrected Visual Acuity (BCVA) | 3 months | 0.55 logMar | Standard Deviation 0.34 |
| Diode MPL | Change in the Best Corrected Visual Acuity (BCVA) | Baseline | 0.58 logMar | Standard Deviation 0.28 |
| Diode MPL | Change in the Best Corrected Visual Acuity (BCVA) | 1 month | 0.57 logMar | Standard Deviation 0.29 |
| Diode MPL | Change in the Best Corrected Visual Acuity (BCVA) | 3 months | 0.52 logMar | Standard Deviation 0.31 |