Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04185701
Other study ID # SiVIEW_refraction_Paris_study
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 1, 2022
Est. completion date June 15, 2023

Study information

Verified date March 2023
Source SiVIEW
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Main objective Show that the equivalent sphere refraction measurements obtained by the SiVIEW software have no significant clinical difference with those obtained by an optometrist expert. Secondary objectives Show that the sphere refraction measurements obtained by the SiVIEW software have no significant clinical difference with those obtained by an optometrist expert. Show that the cylinder refraction measurements obtained by the SiVIEW software have no significant clinical difference with those obtained by an optometrist expert. Show that the visual acuity measurements obtained by the SiVIEW software do not have a significant clinical difference with those obtained by an optometrist expert. Demonstrate that the report delivered for each eye exam by SiVIEW software is consistent and relevant to a vision health practitioner. Show that the differences obtained between two eye examination experts are consistent with those found in the literature.


Description:

Read more »
Read more »

Study Design


Related Conditions & MeSH terms


Intervention

Other:
SiVIEW software
Eye examination by a technician with the SiVIEW software
Expert
Eye examination by an expert including optimal correction in distance and near vision

Locations

Country Name City State
France Ophthalmological Foundation A. de Rothschild Paris

Sponsors (1)

Lead Sponsor Collaborator
SiVIEW

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Equivalent sphere measurement The subject will have an eye exam with SiVIEW and an examination by an optometrist expert. The equivalent sphere value will be evaluated in both cases. At time of inclusion
Secondary Sphere measurement The subject will have an eye exam performed with SiVIEW and by an optometrist expert. The sphere value will be evaluated in both cases. The examination will be started in both cases on the objective measurement value obtained during the routine care examination. At time of inclusion
Secondary Cylinder measurement The subject will have an eye exam performed with SiVIEW and by an optometrist expert. The cylinder value will be evaluated in both cases. The examination will be started in both cases on the objective measurement value obtained during the routine care examination. At time of inclusion
Secondary Visual acuity The subject will have an eye exam performed with SiVIEW and by an optometrist expert. The value of visual acuity will be assessed in both cases. At time of inclusion
Secondary Consistency and relevance of the SiVIEW report After each examination, the report edited by the SiVIEW software will be scored consistently on a Likert scale from 1 to 5 by an expert optometrist:
1: very inconsistent / 2: inconsistent / 3: no opinion / 4: consistent / 5: very consistent
After each examination, the report edited by SiVIEW software will be scored in relevance on a 5 item Likert scale by an expert optometrist:
1: not relevant / not very relevant / no opinion / relevant / very relevant.
At time of inclusion
Secondary Measurement between two optometrist experts Each subject will have an eye examination conducted with an optometrist from the current care centre and by an optometrist expert mandated by SiVIEW (who is used to working at the Rothschild Foundation in clinical studies, among others). The equivalent sphere value will be evaluated in both cases. At time of inclusion
See also
  Status Clinical Trial Phase
Recruiting NCT05414994 - Assessment of the Ocular Microbiome in Health and Disease
Active, not recruiting NCT04271709 - Manhattan Vision Screening and Follow-Up Study (NYC-SIGHT) N/A
Completed NCT02811692 - Study for Collection of Aflibercept Data in Routine Practice
Recruiting NCT06045299 - Evaluation of the Efficacy and Safety of LNZ101 and LNZ100 for the Presbyopia Phase 3
Recruiting NCT01521065 - An Open-label Study to Evaluate the Clinical and Economic Benefits of I-Ray in Patients With Choroidal Neovascularization Secondary to Age-related Macular Degeneration Phase 2
Completed NCT04799704 - Tear Film SARS-nCoV-2 Detection in Symptomatic and Pauci-symptomatic Patients.
Recruiting NCT05876689 - Swept Source OCT Imaging With the DREAM VG-OCT
Active, not recruiting NCT04123626 - A Study to Evaluate the Safety and Tolerability of QR-1123 in Subjects With Autosomal Dominant Retinitis Pigmentosa Due to the P23H Mutation in the RHO Gene Phase 1/Phase 2
Recruiting NCT04150432 - Correlation Between Exhaled Propofol Concentration With Plasma Concentration in Children N/A
Not yet recruiting NCT05550740 - Repeated Low-Level Red-Light Therapy for Shortening Axial Length N/A
Completed NCT02332343 - Sparing of the Fovea in Geographic Atrophy Progression N/A
Completed NCT01727973 - Efficacy of Subantimicrobial Dose Doxycycline for Moderate to Severe and Active Graves' Orbitopathy Phase 1/Phase 2
Terminated NCT01225146 - Study of 2.0 mg Ranibizumab in Subjects With Ischemic Central Retinal Vein Occlusion (RAVE2) Phase 1
Completed NCT00333203 - Next Generation Ophthalmic Irrigating Solution Posterior Segment Study Phase 3
Not yet recruiting NCT05565547 - Multimodal Equipment for Teleophthalmology Assessment (META)
Recruiting NCT05158699 - Effectiveness of Periocular Drug Injection in CATaract Surgery Phase 3
Recruiting NCT06451172 - Novel Antisense Oligonucleotide Eye Drops for Treating Antibiotic-Resistant Bacterial Keratitis Early Phase 1
Recruiting NCT06112340 - A Phase 2b Extension Study of Two Doses of Linsitinib in Subjects With Active, Moderate to Severe Thyroid Eye Disease (TED) Phase 2/Phase 3
Completed NCT05211089 - Manual Versus Automated Choroidal Thickness Measurements Using Swept-source Anterior Segment OCT
Not yet recruiting NCT06070467 - Holistic Mixed Approaches to Capture the Real Life of Children With Rare Eye Diseases