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Proliferative diabetic retinopathy (PDR) is the leading cause for blindness in working-age adults. The current gold standard treatment for PDR is panretinal photocoagulation (PRP). In current clinical practice, both single-session and multiple-session PRP approaches are widely accepted and utilized. The purpose of this study is to compare the safety and effectiveness of single-session and multiple-session PRP.
Proliferative diabetic retinopathy (PDR) is a well-known complication for both type 1 and type 2 diabetes mellitus (DM) and it is the leading cause for blindness in working-age adults. The current gold standard treatment for PDR, established more than four decades ago by the Diabetic Retinopathy Study (DRS), is panretinal photocoagulation (PRP). The treatment goal is to halt the progression of PDR by destroying parts of the peripheral retina in a pattern fashion and hence preserving the visually important central macular region. The tissue destruction reduces the area of ischemia and reduces the production of vascular endothelial growth factor (VEGF), which drives the formation of neovascular proliferations. In the management of PDR, panretinal photocoagulation (PRP) stands as a cornerstone treatment. In current clinical practice, both single-session and multiple-session PRP approaches are widely accepted and utilized. The choice between these approaches often depends on the practitioner's preference, patient characteristics, and specific clinical circumstances.
Although both single-session and multiple-session PRP are employed in practice, there's an ongoing debate regarding their comparative safety and effectiveness. Older studies suggest a heightened risk of diabetic macular edema (DME) with single-session PRP, while newer research, particularly those involving milder laser techniques, indicates that the risk might be similar regardless of the number of sessions. This inconsistency in findings underscores the need for further research and the investigators aim to shed light over this with this prospective, controlled and randomized interventional study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single-session panretinal PRP (SS-PRP) | Active Comparator | Administration of all panretinal photocoagulation (PRP) treatment in one comprehensive session, typically delivered in a single clinical visit. |
|
| Multiple-session panretinal PRP (MS-PRP) | Active Comparator | Administration of panretinal photocoagulation (PRP) treatment over two separate visits with at least one week apart. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Single-session panretinal PRP (SS-PRP) | Procedure | Administration of panretinal photocoagulation (PRP) treatment with navigated laser using Navilas in one comprehensive session, typically delivered in a single clinical visit. |
| Measure | Description | Time Frame |
|---|---|---|
| Central subfield retinal thickness (CRT) | Mean change from baseline in CRT | Baseline and 1, 3 and 6 months after treatment |
| Vessel Perfusion Density (VPD) | Mean change from baseline in VPD | Baseline and 1, 3 and 6 months after treatment |
| Vessel Length Density (VLD) | Mean change from baseline in VLD | Baseline and 1, 3 and 6 months after treatment |
| Foveal Avascular Zone (FAZ) | Mean change from baseline in FAZ | Baseline and 1, 3 and 6 months after treatment |
| Lesion size | Mean change from baseline in lesion size | Baseline and 1, 3 and 6 months after treatment |
| Macular volume | Mean change from baseline in macular volume | Baseline and 1, 3 and 6 months after treatment |
| Venular saturation | Mean change from baseline in venular saturation | Baseline and 1, 3 and 6 months after treatment |
| Arteriolar saturation | Mean change from baseline in arteriolar saturation | Baseline and 1, 3 and 6 months after treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Imadeddin Abu Ishkheidem, M.D. | Contact | +46738744867 | imadeddin.abu.ishkheidem@vgregion.se | |
| Sofia Töyrä Silfverswärd, PhD | Contact | +46761283085 | sofia.toyra.silfversward@vgregion.se |
| Name | Affiliation | Role |
|---|---|---|
| Marita Andersson Grönlund, M.D. Prof | Göteborg University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ögonmottagning Mölndal/SU | Recruiting | Mölndal | 43130 | Sweden |
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Participants will be randomly allocated to either the single-session (SS-PRP) or multiple-sessions (MS-PRP) panretinal photocoagulation groups using a computer-generated sequence. Block randomization will be utilized to ensure balanced group sizes and comparable participant characteristics.
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| Multiple-session panretinal PRP (MS-PRP) | Procedure | Administration of panretinal photocoagulation (PRP) treatment with navigated laser using Navilas over two separate visits with at least one week apart. |
|
| Retinal diameter | Mean change from baseline in retinal diameter | Baseline and 1, 3 and 6 months after treatment |
| Venular diameter | Mean change from baseline in venular diameter | Baseline and 1, 3 and 6 months after treatment |
| Retinal function | Mean change from baseline in retinal function using full-field electroretinogram (ERG) | Baseline and 1, 3 and 6 months after treatment |
| Diabetic macular edema (DME) | Incidence of diabetic macular edema (DME) | Baseline and 1, 3 and 6 months after treatment |
| Subjective experience of pain after treatment | Study patients' subjective experience of pain after treatment using visual analog scale (VAS) | Baseline and 1, 3 and 6 months after treatment |
| Subjective overall experience of the treatment | Study patients' subjective overall experience of the treatment using verbal scale (VS) | Baseline and 1, 3 and 6 months after treatment |
| Cost-effectiveness | We intend to conduct a thorough cost-effectiveness analysis, comparing the single-session approach with the traditional multiple-session treatments. This analysis will factor in direct medical costs, including the expenses related to the laser equipment, healthcare professionals' time, and the required clinical facilities. We will also consider indirect costs such as patient travel expenses and time taken off work. | Baseline and 1, 3 and 6 months after treatment |
| ID | Term |
|---|---|
| D003930 | Diabetic Retinopathy |
| D003922 | Diabetes Mellitus, Type 1 |
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
| D003925 | Diabetic Angiopathies |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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