Safety and Efficacy of TimoD Sustained-Release Implant in Participants With Glaucoma or Ocular Hypertension Undergoing Cataract Surgery
NCT07036510
Cataract, Eye Diseases
Panama City, Panama
View Trial DetailsNCT Number: NCT06827535
This is an observational study involving patients with glaucoma, those with ocular hypertension and healthy subjects.
The aim of the study is the long term evaluation of functional, vascular and morphological changes in glaucoma and ocular hypertensive patients, compared to healthy subjects, to analyze the temporal relationship of these changes.
Interested in participating?
Request Info18 year and older
All sexes
Observational
Ospedale San Paolo - ASST Santi Paolo e Carlo, Milan, Italy
This is an observational study involving patients with glaucoma, those with ocular hypertension and healthy subjects.
The aim of the study is the long term evaluation of functional, vascular and morphological changes in glaucoma and ocular hypertensive patients, compared to healthy subjects, to analyze the temporal relationship of these changes.
Secondary aims of the study are:
During the study patients will undergo BCVA assessment, biomicroscopy, IOP measurement, CCT measurement, gonioscopy, visual field test, optic nerve head and macula OCT scan, OCT angiography scan, fundoscopy, every 6 months (for glaucoma and ocular hypertensive patients) and every 12 months (for healthy subjects). The study lasts 3 years.
Four Italian glaucoma center will partecipate in this study, in addition to the promoter.
Four hundred patients and 100 healthy subjects will be involved.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: Up to 3 years
Rate of progression of functional, morphological and vascular parameters, calculated on the basis of tests repeated over time
Time frame: Up to 3 years
Rate of progression of functional, morphological and vascular parameters, in relation to age
Time frame: Up to 3 years
Rate of progression of functional, morphological and vascular parameters, in relation to myopia
Time frame: Up to 3 years
Rate of progression of functional, morphological and vascular parameters, in relation to clinical and demographic factors collected at baseline (visual acuity, axial length, diagnosis, sex, stage of the disease, etc.)
Time frame: Up to 3 years
Quality of life questionnaire (National Eye Institute Visual Function Questionnaire-25) scores over time.
The minimum value is 0, the maximum value is 100. Higher score means a better outcome.
Mario Stirpe
Other
Acronym: Ippocrate
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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