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NCT Number: NCT06549023

Single Session vs Multiple-Session Panretinal Photocoagulation for Treatment of Proliferative Diabetic Retinopathy

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.

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Key information

Conditions

Proliferative Diabetic Retinopathy Autoimmune Diseases Cardiovascular Diseases Diabetes Complications Diabetes Mellitus Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2 Diabetic Angiopathies Diabetic Macular Edema Diabetic Retinopathy Diabetic Retinopathy Visually Threatening Endocrine System Diseases Eye Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases Retinal Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age > 18 years.
  • Patients with type 1 or type 2 Diabetes Mellitus with newly diagnosed Proliferative Diabetic Retinopathy, PDR.
  • Visual acuity ≥ 0.1 Snellen.
  • CRT of less than 300 micrometer measured by OCT without cysts in the neuroretina.
  • Clear media and adequately dilated pupil for PRP.

Exclusion criteria

  • Intraocular surgery within the last 4 months or planned within the next 3 months.
  • Previous or current center-involved diabetic macular edema (Ci-DME).
  • Previous PRP, intravitreal treatment (IVT), or macular laser treatment in study eye.
  • Treatment with medications known to risk macular edema.
  • Media opacity preventing adequate PRP.
  • General medical condition making office laser treatment very difficult or impossible.

Treatment and study plan

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.

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.

Primary outcomes

  1. Central subfield retinal thickness (CRT)

    Time frame: Baseline and 1, 3 and 6 months after treatment

    Mean change from baseline in CRT

  2. Vessel Perfusion Density (VPD)

    Time frame: Baseline and 1, 3 and 6 months after treatment

    Mean change from baseline in VPD

  3. Vessel Length Density (VLD)

    Time frame: Baseline and 1, 3 and 6 months after treatment

    Mean change from baseline in VLD

  4. Foveal Avascular Zone (FAZ)

    Time frame: Baseline and 1, 3 and 6 months after treatment

    Mean change from baseline in FAZ

  5. Lesion size

    Time frame: Baseline and 1, 3 and 6 months after treatment

    Mean change from baseline in lesion size

  6. Macular volume

    Time frame: Baseline and 1, 3 and 6 months after treatment

    Mean change from baseline in macular volume

  7. Venular saturation

    Time frame: Baseline and 1, 3 and 6 months after treatment

    Mean change from baseline in venular saturation

  8. Arteriolar saturation

    Time frame: Baseline and 1, 3 and 6 months after treatment

    Mean change from baseline in arteriolar saturation

  9. Retinal diameter

    Time frame: Baseline and 1, 3 and 6 months after treatment

    Mean change from baseline in retinal diameter

  10. Venular diameter

    Time frame: Baseline and 1, 3 and 6 months after treatment

    Mean change from baseline in venular diameter

  11. Retinal function

    Time frame: Baseline and 1, 3 and 6 months after treatment

    Mean change from baseline in retinal function using full-field electroretinogram (ERG)

  12. Diabetic macular edema (DME)

    Time frame: Baseline and 1, 3 and 6 months after treatment

    Incidence of diabetic macular edema (DME)

  13. Subjective experience of pain after treatment

    Time frame: Baseline and 1, 3 and 6 months after treatment

    Study patients' subjective experience of pain after treatment using visual analog scale (VAS)

  14. Subjective overall experience of the treatment

    Time frame: Baseline and 1, 3 and 6 months after treatment

    Study patients' subjective overall experience of the treatment using verbal scale (VS)

  15. Cost-effectiveness

    Time frame: Baseline and 1, 3 and 6 months after treatment

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Imadeddin Abu Ishkheidem, M.D.

CONTACT

[email protected]

+46738744867

Sofia Töyrä Silfverswärd, PhD

CONTACT

[email protected]

+46761283085

Sponsors and collaborators

Lead sponsor

Vastra Gotaland Region

Other Gov

Registry information

Official study title

Single Session vs Multiple-Session Panretinal Photocoagulation With Navigated Laser in Proliferative Diabetic Retinopathy - The SMART-PRP Study

Acronym: SMART-PRP

Important dates

Study start
2025
Primary completion
2028
Study completion
2030
First posted
Aug 12, 2024
Registry last updated
Nov 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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