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Intraocular Pressure clinical trials

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NCT ID: NCT05716945 Not yet recruiting - Clinical trials for Intraocular Pressure

The OPTIMISE Study

Start date: March 1, 2023
Phase: Phase 4
Study type: Interventional

Rationale: The cornea is the most transplanted tissue in the Netherlands, with more than 1,500 procedures performed each year. A minimally invasive technique called Descemet Membrane Endothelial Keratoplasty (DMEK) has become the preferred method in the past decade. The main advantage of DMEK over previous techniques is a low graft rejection rate (1-2% per year). Despite this, rejection prophylaxis after DMEK follows the same high potency regimen as previous techniques in the first year, and patients are burdened with indefinite immunosuppression. The current project, OPTIMISE, aims to establish an evidence-based, cost-effective regimen that effectively prevents rejection and minimizes side effects. Corticosteroid eye drops are the mainstay of ocular immunomodulatory therapy. Their main side effect is a steroid-induced increase in intraocular pressure (IOP). It manifests in about one-fourth of patients within the first year after surgery and can lead to irreversible optic nerve damage and vision loss. Patients with IOP elevation require additional medications and hospital visits resulting in reduced quality of life and increased costs. The optimal dosing regimen in the first year after DMEK and whether patients may safely stop steroids after one year remains unknown. As a result, protocols in the Netherlands vary considerably from surgeon to surgeon. Patients are potentially over-treated in the short and long-term, resulting in undue burden for the patient and increased costs. Consequently, the Dutch Ophthalmology Society (NOG) identified the optimal short- and long-term immunosuppressive protocol for corneal transplantation as one of its Top 10 knowledge gaps, underscoring relevance for clinical practice. With this work, the investigators expect to address this knowledge gap to the benefit of our patients and society. Objective: The OPTIMISE study aims to establish an evidence-based, cost-effective regimen that effectively prevents rejection and minimizes side effects. The hypothesis of this study is that Fluorometholone 0.1% in the first year and discontinuing medication in the second year is a cost-effective treatment strategy after DMEK. Study design: The design of this study is a randomized, controlled multicentre trial with a duration of 24 months. Study population: The study population will consist of 342 patients aged 21 years or older undergoing DMEK surgery in one eye. Intervention: All patients will receive Descemet's Membrane Endothelial Keratoplasty. Following this procedure, patients will be randomized into the following post-operative regime in two stages: STEP-I (Year 1): Control group: DMS 0.1% 6 times a day for 1 month tapered off to once daily within 6 months and then once a day for 6 months. Intervention group: DMS 0.1% 6 times a day for 1 month followed by FML 0.1% 4 times a day for two months tapered off to once daily within four months and then once a day for 6 months. STEP-II (Year 2): Control Group: Half the patients in each study arm will use FML 0.1% daily. Intervention Group: Half the patients in each study arm will discontinue steroids. Main study parameters/endpoints: Primary outcomes: Step-I: IOP elevation compared to baseline Step-II: Endothelial cell loss (ECL) compared to pre-surgical baseline Secondary outcomes are: - Rejection free graft survival. - Patient reported outcome measures. - Incremental cost-effectiveness ratios, including a short term trial-based economic evaluation (TBEE) and a life-long model-based economic evaluation (MBEE) - Structural outcomes including corneal, central macular and retinal nerve fibre layer thicknesses, and optic nerve head imaging.

NCT ID: NCT05466526 Recruiting - Clinical trials for Primary Open Angle Glaucoma

Microinvasive Glaucoma Surgery -The Lowering Effect of Intraocular Pressure on Glaucoma Patients With High Frequency Deep Sclerotomy

HFDS
Start date: July 1, 2022
Phase: N/A
Study type: Interventional

Highlights the high-frequency deep sclerotomy (HFDS) as a promising ab-interno surgery in primary open-angle glaucoma (POAG) patients and evaluates the efficacy and safety of the procedure.

NCT ID: NCT05352906 Recruiting - Glaucoma Clinical Trials

Accuracy of Handheld and Non-contact Tonometry

Start date: April 20, 2022
Phase: N/A
Study type: Interventional

Monitoring the intraocular pressure (IOP) is one of the most important tests used in follow-up among glaucoma suspects and confirmed glaucomatous patients.

NCT ID: NCT05288192 Recruiting - Cataract Clinical Trials

Changes After Suprachoroidal Injection.

Start date: February 15, 2022
Phase: N/A
Study type: Interventional

Changes after suprachoroidal injection are analyzed for statistical analysis.

NCT ID: NCT05167773 Completed - Clinical trials for Intraocular Pressure

Clinical Study of the Topcon Tonometer TRK-3

Start date: October 11, 2021
Phase:
Study type: Observational

The study will assess the TRK-3 for conformity to ISO 8612:2009, JIS T7312:2015, and ANSI Z80.10-2014 Ophthalmic Instruments - Tonometers, to the FDA Guidance for Industry and FDA Staff, Tonometer-Premarket Notification [510(k)] Submissions, and the applicable Supplemental Information Sheet.

NCT ID: NCT05162989 Completed - Glaucoma Clinical Trials

iCare HOME2 Clinical Trial

Start date: November 26, 2021
Phase: N/A
Study type: Interventional

The aim of this clinical study is to provide information about the variability of the intraocular pressure (IOP) self-measurements with the iCare HOME2 tonometer in comparison to the variability of the IOP measurements with the reference tonometer (iCare IC200), over a wide range of IOP values.

NCT ID: NCT04970251 Completed - Clinical trials for Intraocular Pressure

Aflibercept as Adjunctive Treatment for Filtration Surgery in Neovascular Glaucoma

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

Purpose: To investigate intravitreal aflibercept (IVA) injection as an adjunctive treatment to trabeculectomy with mitomycin C (TMC) and panretinal photocoagulation (PRP) for neovascular glaucoma (NVG). Setting: Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand Study design: Prospective interventional case series Methods: PRP and IVA (2 mg/0.05 ml) injection were given, and TMC was performed within 2 weeks after IVA. Additional PRP, laser suture lysis, subconjunctival 5-fluorouracil injection, and bleb needling were performed after TMC if indicated. Best-collected visual acuity (BCVA), intraocular pressure (IOP), surgical complications, and number of anti-glaucoma medications were collected.

NCT ID: NCT04949347 Completed - Glaucoma Clinical Trials

Glycerin-Preserved, Human-Donor, Corneoscleral Patch Grafts for Glaucoma Drainage Devices

Start date: February 22, 2017
Phase:
Study type: Observational

This was a retrospective, non-comparative study of 100 eyes of 100 consecutive glaucoma patients who had undergone glaucoma drainage device implantation (Baerveldt shunt) during January 2006 to December 2016. Glycerin-preserved, human-donor, corneoscleral tissue was used as a patch graft to cover the tube portion of the GDD over the sclera. The patch graft related complication was comparable to the previous reports using conventional sclera or pericardium.

NCT ID: NCT04868175 Completed - Glaucoma Clinical Trials

Interval Intraocular Pressure in Intravitreal Injection Study

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

This is a prospective study of IOP in Intravitreal injections to evaluate: 1. IOP effect of intravitreal injection 2. IOP response to prophylactic beta blocker or Prostaglandin vs control (Hypromellose) over multiple time periods 3. IOP response in correlation to number of injections, IOL, type of anti VEGF, co morbidities

NCT ID: NCT04863209 Completed - Clinical trials for Intraocular Pressure

Effect of Osteopathic Techiniques on Intraocular Pressure

Start date: September 28, 2021
Phase: N/A
Study type: Interventional

The purpose of this study is to assess the effects osteopathic techniques at the upper cervical vertebrae or at the sphenopalatine ganglia on the intraocular pressure.