CDL Validation Study

NCT05461469 | Completed DMC

• 1 other identifier: 2021-01-CDL
• Study Type: observational
• Target: 104
• Locations: 1 country
• Sites: 1

Brief Summary

Ocular surface photography is significantly limited in standardization and reproducibility. This reduces its applicability for clinical monitoring of acute or chronic disease. The innovative lens and illumination design of the CDL system aims to yield standardized high resolution photographs of the cornea and conjunctiva as required for clinical documentation, posing a significant clinical benefit of health care providers in the field of ophthalmology. Primary objectives: The primary objective of this study is to test the safety and feasibility of the CDL imaging system in a clinical routine setting. This will include the comparison of subjective contrast sensitivity testing post imaging, and the measurement of examination duration per imaging session, and the comparison of image lightness in mesopic versus photopic imaging. Secondary objectives: The secondary objective of this study is to compare the image quality of the device and repeatability of lateral resolution, dynamic range, hue, saturation, lightness, and image position between colour photographs from a state-of the art slit lamp camera and the CDL system. This is a monocentric, prospective, observational study. Patients with ocular surface disease of variable aetiology routinely assigned to ocular surface photography, following informed consent, will be imaged using state-of-the-art colour photography and the CDL imaging system. Pictures of each patient will be taken under several standardized conditions with both methods, subsequently analysed and compared by a Medical Image Processing Specialist.

Conditions

Eyes Dry Chronic; Chronic Conjunctivitis of Both Eyes; Limbal Stem-cell Deficiency; Eye Lesion; Eye Disease; Cataract; Eyes Dry Feeling of; Cornea Disease; Cornea Inflamed; Cornea; Injury, Abrasion; Cornea Infection

Keywords

Ocular surface; Imaging; Cornea; Conjunctiva; Dry eye disease

Outcome Measures

Primary Outcomes (5)

• Contrast sensitivity testing post imaging with either CDL or the slit lamp.

  Safety and feasibility of the CDL in clinical routine use, will be assessed by the contrast sensitivity test 30 minutes after imaging with either the CDL system or the the slit Lamp. Contrast sensitivity testing measures how well the eyes can distinguish between finer and finer light increments compared to dark. Pelli-Robson contrast sensitivity chart will be applied to the patient. This consists of rows of letters that become gradually less contrasted. They start a dark black and progress into a faint grey. The letters are on a white background. This test allows the doctor to determine the lightest contrast the patient can successfully see.

  During the procedure

• Severity and Risk of AE

  Eye damage due to illumination power exceeding applicable illumination limits -Patient discomfort from illumination-Blurred vision, after image, headache or dizziness after fixating the light target-Head trauma from bumping head against frame of device-Irritation of forehead, chin and hands which are in contact with the ophthalmic table and chin rest, following the use of disinfectants.

  up to 72 hours

• Severity and Risk of SAEs.

  Death, serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following: a life-threatening illness or injury, or a permanent impairment of a body structure or a body functions including chronic diseases, or in-patient or prolonged hospitalization, or medical or surgical intervention to prevent life-threatening illness or injury, or permanent impairment to a body structure or a body function, fetal distress, fetal death, a congenital abnormality, or birth defect including physical or mental impairment.

  through the study completion, an average of one year

• Examination duration for series-of-3 photographs.

  The total exposure to the source of light should not exceed 7 minutes and 40seconds. The duration of taking 3 photographs of an eye will be measured.

  During the procedure

• Image lightness in mesopic versus photopic imaging.

  The impact of the light in producing high quality photographs of the eye surface will be tested in mesopic room conditions (lights off) with the CDL and slit lamp and in photopic room conditions (lights on).

  During the procedure.

Secondary Outcomes (2)

• Lateral resolution on corneal apex, limbus, and peripheral conjunctiva.

  During the procedure

• Repeatability of lateral resolution, dynamic range, hue, saturation, lightness and image position.

  During the procedure

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients will be recruited from the corneal outpatient clinics of PMU. Participants will be given an information leaflet to read and a qualified and delegated physician will explain and discuss the study with the patients. If they are interested in participating, they will be asked to sign and return the study specific consent form. Every patient has the opportunity to withdraw from the study without compromise to their continued care. The reason for withdrawal from the study will be documented if volunteered. This will provide information to improve future study designs in this area of investigation.

You may qualify if:

• Patients with ocular surface or anterior segment disease
• Written, signed and dated informed consent from the trial subject has been obtained

You may not qualify if:

• Current Participation in other interventional trials
• Patients unable to fixate a target
• Patients less than 18 years old
• Persons with any kind of dependency on the investigator or employed by the sponsor or investigator
• Persons held in an institution by legal or official order
• Patients with incapacity
• Pregnant or breastfeeding women

Sponsors & Collaborators

• Occyo GmbH: lead
• University Clinic for Ophthalmology and Optometry- Salzburg: collaborator

Study Sites (1)

Department of Ophthalmology and Optometry, Paracelsus Medical University Salzburg

Salzburg, 5020, Austria

Location

Related Publications (8)

• Ang M, Cai Y, MacPhee B, Sim DA, Keane PA, Sng CC, Egan CA, Tufail A, Larkin DF, Wilkins MR. Optical coherence tomography angiography and indocyanine green angiography for corneal vascularisation. Br J Ophthalmol. 2016 Nov;100(11):1557-1563. doi: 10.1136/bjophthalmol-2015-307706. Epub 2016 Jan 28.

  PMID: 26823396 BACKGROUND

• Steger B, Romano V, Kaye SB. Corneal Indocyanine Green Angiography to Guide Medical and Surgical Management of Corneal Neovascularization. Cornea. 2016 Jan;35(1):41-5. doi: 10.1097/ICO.0000000000000683.

  PMID: 26555579 BACKGROUND

• McMonnies CW, Chapman-Davies A. Assessment of conjunctival hyperemia in contact lens wearers. Part I. Am J Optom Physiol Opt. 1987 Apr;64(4):246-50. doi: 10.1097/00006324-198704000-00003.

  PMID: 3591894 BACKGROUND

• Bron AJ, Evans VE, Smith JA. Grading of corneal and conjunctival staining in the context of other dry eye tests. Cornea. 2003 Oct;22(7):640-50. doi: 10.1097/00003226-200310000-00008.

  PMID: 14508260 BACKGROUND

• Guthoff RF, Baudouin C, Stave J. Atlas of Confocal Laser Scanning In-Vivo Microscopy in Ophthalmology. Springer; 2007

  BACKGROUND

• Krachmer JH, Mannis MJ, Holland EJ. Cornea. In: Vol I. 3rd Edition. Mosby Elsevier; 2011.

  BACKGROUND

• Steger B, Romano V, Jesacher A, et al. Ocular Surface Photography 2.0 -Curved Object Plane For Corneal Imaging. Appl Opt. in press 2017

  BACKGROUND

• Efron N. Grading scales for contact lens complications. Ophthalmic Physiol Opt. 1998 Mar;18(2):182-6. doi: 10.1016/s0275-5408(97)00066-5.

  PMID: 9692040 BACKGROUND

MeSH Terms

Conditions

Limbal Stem Cell Deficiency; Cataract; Corneal Diseases; Keratitis; Corneal Injuries; Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Eye Diseases; Lens Diseases; Eye Injuries; Facial Injuries; Craniocerebral Trauma; Trauma, Nervous System; Nervous System Diseases; Wounds and Injuries; Lacrimal Apparatus Diseases

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2022
• First Posted: July 18, 2022
• Study Start: April 22, 2022
• Primary Completion: June 26, 2023
• Study Completion: June 26, 2023
• Last Updated: April 4, 2024

Record last verified: 2024-04

Locations

AU (1)