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To compare the retinal image quality taken from two different OCT machines

A prospective comparative observational study to assess retinal layers using Aurolab’s Retinal Optical Coherence Tomography versus Heidelberg engineering OCT - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/10/096369
Enrollment
242
Registered
2025-10-22
Start date
Unknown
Completion date
Unknown
Last updated
2025-11-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: H36- Retinal disorders in diseases classified elsewhere

Interventions

Intervention1: Optical Coherence Tomography: Patients with retinal disorders will be examined using Aurolab Retinal OCT to investigate the disease/disorder progression Control Intervention1: Optical C

Sponsors

Aurolab
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Patients of age 18 years or above 2. Patients diagnosed DR, ARMD, CNVM, Macular edema, RD and other pathologies which can be diagnosed through OCT. 3.Clear ocular media (LOCS III nuclear sclerosis 2 or below Grade 2, no significant corneal opacities) and free of floaters. 4. Pupillary dilation greater than or equal to 6 mm. 5. Ability to provide informed consent and cooperate for OCT imaging. 6. Willing to undergo imaging on both devices.

Exclusion criteria

Exclusion criteria: 1.Dense cataract or media opacities (e.g., mature cataract, significant vitreous hemorrhage) that preclude quality of OCT imaging. 2. Eyes with severe corneal pathology or poor fixation (e.g., central leucoma, band keratopathy). 3. History of recent intraocular surgery within the past 6 weeks in either eye. 4. Active intraocular inflammation (e.g., uveitis) or infection (e.g., endophthalmitis). 5. Presence of severe nystagmus or neurological disorders affecting fixation. 6. Inability to comply with study procedures or follow instructions for imaging.

Design outcomes

Primary

MeasureTime frame
1.Image quality including clarity, signal strength, layer segmentation and diagnostic accuracy in comparison to standard OCT 2. Ease of use and safety of the device. Timepoint: 0

Secondary

MeasureTime frame
NILTimepoint: NIL

Countries

India

Contacts

Public ContactDr M Sivadharsan

Aravind Eye Hospital

sivadarshan@aravind.org9791034271

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026