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Keratoconus clinical trials

View clinical trials related to Keratoconus.

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NCT ID: NCT05457647 Completed - Keratoconus Clinical Trials

Theranostic Guided Riboflavin/UV-A Corneal Cross-linking

ARGO
Start date: April 27, 2022
Phase: N/A
Study type: Interventional

This is a clinical study consisting of a study arm to assess the performance of the theranostic software module (Research Use Only) of a CE marked (CE1936) UV-A medical device, C4V CHROMO4VIS™, in order to validate its use for theranostic-guided corneal cross-linking treatment of keratoconus and corneal ectasia. The study hypothesis is that theranostic-guided riboflavin/UV-A corneal cross-linking with the C4V CHROMO4VIS™ system is safe and can estimate treatment efficacy during operation, regardless of treatment protocol, i.e., either with or without epithelial removal.

NCT ID: NCT05279157 Completed - Keratoconus Clinical Trials

Autologous Adipose-Derived Adult Stem Cell Implantation for Corneal Diseases (ADASCs-CT-CD)

ADASCs-CT-CD
Start date: April 19, 2022
Phase: Phase 2
Study type: Interventional

Cellular therapy of the corneal stroma with implantation of mesenchymal stem cells derived from autologous adipose tissue with or without a carrier (scaffold) composed by decellularized human donor corneal stroma is used in patients with corneal diseases such as corneal dystrophies, and keratoconus. For this purpose, the study planned to assess the enhancement of visual acuity, pachymetric, and aberrometric parameters with implantation of autologous mesenchymal adipose tissue-derived adult stem cells (ADASCs) alone, 120 µm thickness of decellularized or recellularized laminas with ADASCs. Three groups will be included in the study: (1) Implantation of a single dose of ADASCs alone without scaffold. (2) Implantation of decellularized human corneal lamina without ADASCs. (3) Implantation of the recellularized human corneal lamina with ADASCs.

NCT ID: NCT05241145 Completed - Keratoconus Clinical Trials

Safety and Preliminary Efficacy of IVMED-80 Eye Drops in Keratoconus Patients

Start date: February 8, 2019
Phase: Phase 1/Phase 2
Study type: Interventional

We investigated the use of a copper sulfate eye drop (IVMED-80) for the treatment of keratoconus. Preliminary laboratory data shows that the addition of copper sulfate increase crosslinking of the structural proteins of the cornea thereby halting the progressing corneal thinning and bulging seen in keratoconus. We conducted a Phase 1/2a study to evaluate the safety and preliminary efficacy of a 6-week and a 16-week regimen using IVMED-80 and studied its impact on ocular safety and the change/progression in patients' vision and clinical measurements.

NCT ID: NCT05114928 Completed - Keratoconus Clinical Trials

Correlation Between Q-value Changes and Progression of Pediatric Keratoconus.

Start date: October 9, 2021
Phase:
Study type: Observational

Keratoconus is a progressive corneal disease characterized by asymmetric corneal thinning and structural changes in corneal collagen which leads to decrease in visual acuity due to myopic shift, irregular astigmatism or corneal scarring. Early detection of the disease in children aids in halting the progression and improve their quality of life. There is no consensus regarding the progression criteria of the disease, we aimed to assess the changes in corneal asphericity in children after corneal collagen crosslinking and investigate any possible correlation with progression criteria widely used.

NCT ID: NCT05073601 Completed - Keratoconus Clinical Trials

Thyroid Gland Dysfunction and Vitamin D Polymorphism in Keratoconus

Start date: March 6, 2021
Phase:
Study type: Observational

This prospective study the thyroid gland dysfunction and vitamin D receptor polymorphism in keratoconus patients

NCT ID: NCT05019768 Completed - Keratoconus Clinical Trials

Topo-pachimetric Accelerated Epi-On Cross-linking Compared to Dresden Protocol Using Riboflavin With Vitamin E TPGS

Start date: September 1, 2017
Phase: N/A
Study type: Interventional

In the present study the investigators compare the clinical outcome corneal cross linking with either the stand-ard Dresden (sCXL) or the accelerated custom-fast (aCFXL) ultraviolet A irradiation protocol using riboflavin-D-α-Tocopheryl polyethyleneglycol1000 succinate for progressive keratoconus.

NCT ID: NCT04748198 Completed - Keratoconus Clinical Trials

Effect of Intracorneal Ring Segments on Posterior Corneal Tomography in Eyes With Keratoconus

Start date: June 10, 2018
Phase: N/A
Study type: Interventional

Our purpose is to analyze the changes induced in the posterior corneal surface in patients implanted with intracorneal ring segments for treatment of keratoconus. Patients are assessed with corneal imaging device preoperatively and at 1, 3, 6 and 12 months postoperatively.

NCT ID: NCT04649177 Completed - Dry Eye Syndromes Clinical Trials

Pilot Study to Investigate the Feasibility, Reliability and Efficacy of Utilizing OCT to Automate PROSE Fitting

Start date: December 15, 2020
Phase: N/A
Study type: Interventional

EYEdeal Scanning Technology enables rapid measurement of corneal and scleral topography. By accurately measuring the ocular surface with this imaging technology, the current iterative fitting method required to fit PROSE (prosthetic replacement of the ocular surface ecosystem) devices could be replaced and/or strengthened with a more rapid, automated fitting sequence. This could considerably reduce the time needed per visit, the number of visits, and the number of devices needed to be manufactured to reach the endpoint. Additionally, the scanning technology may afford the opportunity to successfully fit some pathology that were previously treatment failures. The automated technology may as well reduce the intensive clinician training time needed to fit PROSE devices, therefore increasing the availability and access to patients. The goal of this research is to evaluate the reliability and efficacy of this automated technology for fitting PROSE devices. Data from real-time measurement of the human eye ocular surface topography will be used to fabricate a prosthetic lens. The fit of the PROSE device will be evaluated, as well as the subjective comfort of the fit.

NCT ID: NCT04532788 Completed - Keratoconus Clinical Trials

Efficacy of Customized Corneal Cross-linking vs. Standard Corneal Cross-linking

C-CROSS
Start date: March 1, 2021
Phase: N/A
Study type: Interventional

The standard or Dresden protocol was established in 2003 and treats the entire cornea. However, recent ultra-structural research showed that keratoconus is localized. Therefore, treating only the affected zone and minimalizing the risk of damaging surrounding tissues would be beneficial. The objective of this study is to evaluate whether the effectiveness of customized cross-linking (cCXL) is non-inferior to standard accelerated cross-linking (sCXL) in terms of flattening of the cornea and halting keratoconus progression.

NCT ID: NCT04517903 Completed - Keratoconus Clinical Trials

Validation Study on Eye Rubbing Questionnaire in Patients With or Suspected of Having a Keratoconus (KC)

QFK
Start date: March 16, 2021
Phase: N/A
Study type: Interventional

KC is a degenerative disorder of the cornea. Keratoconus etiopathogenesis remains unclear and may rely on environmental and genetic factors. Usually considered as a rare disease (<1/2000), but the prevalence is nowadays growing worldwide up to 1/500. In that pathology, cornea progressively gets thinner, and there is a deformation of the corneal surface which can induce high order optical aberrations and visual impairment. Eye rubbing is certainly the main factor in the progression or development of keratoconus (KC), yet it is only very partially evaluated and quantified in current management. Environmental and clinical factors will be collected and associated with a eye rubbing Questionnaire, specifically pointing out eye rubbing.