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Keratoconus clinical trials

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NCT ID: NCT06312163 Completed - Keratoconus Clinical Trials

Validation of Innovative Scheimpflug Topography Derived RGP Contact Lens Designs In Optometry Network

VISION
Start date: June 6, 2022
Phase:
Study type: Observational

The goal of this Prospective, single-site, cohort study is to validate rigid gas permeable corneal contact lens (RGP) designs for keratoconus derived from combining the data from corneal topography scans and contact lenses ordered in patients with keratoconus (KC) attending a UK tertiary NHS Hospital contact lens clinic. The main questions it aims to answer are: - Does a Scheimpflug topography derived RGP contact lens design for keratoconus have the equivalent overall contact lens fit as the patients' own lens? - Is the number of trial lenses required to fit a patient is reduced compared to standard practice? - Is the time taken to fit a contact lens is reduced compared to standard practice? - Is there user acceptance of the new lens? - Are the Axial ege lift (AEL) changes clinically significant? There will be 3 work packages WP1: For each participant data collection will take place over two visits. • Visit 1: Pentacam topography scans and optimal 'virtual' lens selection will take place. • • Visit 2: Participants are fitted with 4 contact lenses (i) the optimal lens design as specified by the virtual fitting module, (ii) a contact lens with a clinically significant step flatter AEL (iii) a contact lens steeper in axial edge lift (AEL) (iv) the participant's own contact lens. Each CL fit will be assessed with slit lamp photography according to the standardised method proposed by Wolffsohn et al. (2013), Anterior segment OCT MS39) (CSO Hansom Instruments, UK) and best-corrected visual acuity with each lens design using high-contrast logMAR . WP2. Participants will attend one appointment where a traditional lens fit, and a lens fitted using the topography guided 'virtual' module will be undertaken (with the fitting method selected for each eye randomised). For each fitting method the total fitting time will be measured and the total number of trial contact lenses used. Patients will be invited to complete a questionnaire that probes their satisfaction of this process. WP3. Clinicians not involved in the study will be invited to examine a demo version of the virtual fitting module and complete the validated system usability scale tool.

NCT ID: NCT06267495 Completed - Keratoconus Clinical Trials

Epithelium-on Cross-linking Versus Observation of Fellow Eyes of Patients With Unilateral Clinically Evident Keratoconus

Start date: January 1, 2017
Phase:
Study type: Observational

Keratoconus (KC) is a bilateral asymmetric progressive corneal degenerative disease. The management of young patients, diagnosed with clinically evident KC in one eye and with no clinical signs of KC in the other eye, represents a real challenge for many ophthalmologists. The aim of the current study is to investigate the effectiveness and safety of epithelium-on accelerated CXL to stabilize the eye with no clinical signs of KC, in young patients with unilateral clinically evident KC, compared with standard care and follow-up only.

NCT ID: NCT06243991 Completed - Keratoconus Clinical Trials

The Effect Of High And Low Molecular Weight Sodium Hyaluronic Acid Eye Drops After Crosslinking

Start date: March 1, 2021
Phase:
Study type: Observational [Patient Registry]

Purpose: The objective of this investigation was to assess the impact of eye drops containing high molecular weight hyaluronic acid (HMW-HA) and low molecular weight hyaluronic acid (LMW-HA) on corneal nerve regeneration, dendritic cell (DC) density, corneal sensitivity (CS), and ocular surface parameters in patients with keratoconus following corneal crosslinking (CXL). Methods: Sixty-three eyes of 55 keratoconus patients were randomized to instill eye drops containing HMW-HA (n: 20) for 12 months, LMW-HA (n:23) for 12 months and polyvinyl alcohol (n: 20) until the epithelial defect closure in the control group after CXL. Subbasal nerve plexsus (SNP) was imaged with corneal confocal microscopy (CCM) and ACCMetrics program was used to quantify corneal nerve fiber density (CNFD), corneal nerve fiber length (CNFL), corneal nerve fiber branching density (CNBD) and corneal nerve fiber total branching density (CTBD). DC density was calculated with Image J software. CS was measured using the Cochet-Bonnet esthesiometer. Ocular Surface Disease Index (OSDI) questionnaire, non-invasive break-up time (NI-TBUT) were evaluated. All measurements were performed before CXL and postoperatively after 1, 3, 6 and 12 months.

NCT ID: NCT06050629 Completed - Clinical trials for Elasticum, Incomplete Pseudoxanthoma

The Characteristics of Backscattering With Depth in the Progression of Keratoconus

Start date: January 1, 2020
Phase:
Study type: Observational

To investigate the variation in backscattering with depth between forme fruste keratoconus (FFKC), keratoconus, and normal eyes; to determine the backscattering changes in the characteristics of keratoconus progression; and to explore the diagnostic value of backscattering in FFKC.

NCT ID: NCT05756062 Completed - Keratoconus Clinical Trials

Supplementation With a Highly-Concentrated Docosahexaenoic Acid (DHA) Triglyceride in Patients With Keratoconus

Start date: February 1, 2019
Phase: N/A
Study type: Interventional

The goal of this randomized controlled preliminary study is to assess the effect of daily supplementation with a nutraceutical formulation of a highly-concentrated DHA triglyceride plus minerals on ophthalmological parameters and biomarkers of oxidative stress and inflammation in blood samples of patients with keratoconus.The main questions it aims to answer are: - Improvements in ophthalmological parameters. - Increase in antioxidant capacity, decrease in inflammatory status, and changes in lipidomic biomarkers. Participants are patients with keratoconus who will be given the nutraceutical supplementation for 3 months. If there is a comparison group: Researchers will compare patients with keratoconus not given the nutraceutical formulation to see differences in the study variables

NCT ID: NCT05748847 Completed - Keratoconus Clinical Trials

Pocket Versus Tunnel ICRS for Treatment of Keratoconus

Start date: June 1, 2019
Phase: N/A
Study type: Interventional

Keratoconus is a corneal degenerative disease associated with loss of best-corrected visual acuity. The use of intrastromal corneal ring segment implants is indicated to regularize the cornea and to reduce aberrations.

NCT ID: NCT05748002 Completed - Keratoconus, Stable Clinical Trials

Evaluation of Morphology Abnormal Cornea Stability With Corneal Biomechanical

Start date: July 16, 2018
Phase:
Study type: Observational

To evaluate the corneal biomechanical properties of stable eyes with abnormal morphology, and introduce a biomechanical stable index to evaluate the stability of the eyes with abnormal morphology at the first diagnosis.

NCT ID: NCT05691335 Completed - Corneal Ectasia Clinical Trials

Three Different Cross-linking Protocols for Treatment of Pediatric Keratoconus

Start date: June 1, 2018
Phase: N/A
Study type: Interventional

comparison between standard cross-linking protocol and accelerated and transepithelial cross-linking

NCT ID: NCT05604443 Completed - Keratoconus Clinical Trials

Keratoconus Detection Using MS39 and Pentacam

KKMS39Penta
Start date: December 28, 2022
Phase:
Study type: Observational

This retrospective study aims to investigate whether the MS39 and Pentacam are delivering comparable results in the diagnosis of keratoconus. In the future, these measurement devices could be interchangeable in usage.

NCT ID: NCT05572580 Completed - Clinical trials for Keratoconus, Unspecified, Bilateral

Evaluation of the German Version of a Validated Keratoconus Questionaire

KORQ
Start date: August 11, 2022
Phase:
Study type: Observational

Keratoconus, which results in thinning of the cornea, affects mainly young patients. The causes are currently only partially known. The aim of this study is the evaluation of a keratoconus questionnaire in German. Until now this questionnaire is only in use in English. Within the study patients will be asked to fill out a questionnaire. The questionnaire deals with issues that are influenced by keratoconus: Visual impairment and its impact on quality of life. This questionnaire (KORQ) is an already validated questionnaire in English. Within this study we would like to translate the questionnaire and validate it in German. Within this study 50 patients will be included for the validation of the questionnaire. Based on previous studies evaluating the Keratoconus Questionnaire (KORQ) in other languages, a number of 50 patients has been shown to be sufficient for validation. No control examination is necessary for this study.