Ocular Changes in Patients Using Tirzepatide or Semaglutide

Condition(s) studied

Investigational drug(s) / intervention(s)

Semaglutide: Semaglutide is prescribed as part of routine clinical care. Treatment is not assigned by the study protocol. Ocular structural and vascular parameters are evaluated before treatment and during follow-up.

Tirzepatide: Tirzepatide is prescribed as part of routine clinical care. Treatment is not assigned by the study protocol. Ocular structural and vascular parameters are evaluated before treatment and during follow-up.

Study summary

This prospective observational study aims to evaluate ocular structural and microvascular changes in adults with obesity who are receiving semaglutide or tirzepatide as part of routine clinical care. Participants with and without type 2 diabetes mellitus will be included.

Participants will undergo ophthalmologic examinations at baseline and during follow-up. Changes in optic nerve head parameters, retinal thickness, retinal and choroidal microvascular parameters, and choroidal thickness will be assessed using optical coherence tomography (OCT), optical coherence tomography angiography (OCT-A), and other routine ophthalmologic examination methods.

The study will compare ocular measurements obtained at baseline and during follow-up to investigate changes associated with semaglutide or tirzepatide treatment over a period of up to 18 months.

Eligibility

Primary outcome measure(s)

• Change in Retinal Nerve Fiber Layer Thickness — Baseline to up to 18 months
  Change in retinal nerve fiber layer thickness from baseline during follow-up, assessed using optical coherence tomography (OCT).
• Change in Retinal Thickness — Baseline to up to 18 months
  Change in retinal thickness from baseline during follow-up, assessed using optical coherence tomography (OCT).
• Change in Superficial Retinal Vessel Density — Baseline to 18 months
  Change in superficial retinal capillary vessel density from baseline to follow-up, assessed using optical coherence tomography angiography (OCT-A) and expressed as a percentage (%).
• Change in Deep Retinal Vessel Density — Baseline to 18 months
  Change in deep retinal capillary vessel density from baseline to follow-up, assessed using optical coherence tomography angiography (OCT-A) and expressed as a percentage (%).
• Change in Foveal Avascular Zone Area — Baseline to 18 months
  Change in foveal avascular zone (FAZ) area from baseline to follow-up, measured using optical coherence tomography angiography (OCT-A) and expressed in square millimeters (mm²).
• Change in Choriocapillaris Flow Deficit Percentage — Baseline to 18 months
  Change in choriocapillaris flow deficit percentage from baseline to follow-up, assessed using optical coherence tomography angiography (OCT-A) and expressed as a percentage (%).

Trial sites (1)

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