An observational study in Chronic Obstructive Pulmonary Disease and Glaucoma, Angle-Closure, sponsored by Giresun University. Completed at 1 site in Turkey. Open to participants aged 47 Years to 82 Years. Per ClinicalTrials.gov, last updated 2024-07-29.
Sponsored by Giresun University · Observational
This study aimed to examine the effect of Tiotropium, which is used in the treatment of COPD, on eye symptoms.The study was conducted prospectively. Patients were examined in three groups. Thirty-six patients were included in each group in the study. Anterior chamber parameters, intraocular pressure values, and photopic-mesopic pupil diameters were measured at the initial visit for Group 1 and Group 2 patients, and at the third month of treatment for Group 3 patients.
Chronic obstructive pulmonary disease (COPD) is a persistent, chronic inflammatory disease of the lungs. Tiotropium, used in the treatment of COPD, is a muscarinic receptor antagonist that provides long-acting bronchodilation. In this study the researchers aimed to investigate the effects of Tiotropium on eye anterior chamber parameters.
The study was conducted prospectively between October 2023 and April 2024 after obtaining local Ethics Committee approval (Giresun EAH KEAK 2023/180 and 9.10.2023/02). Patients diagnosed with COPD and included in Group A according to the GOLD 2024 guidelines, along with healthy volunteers, were enrolled. Patients diagnosed with COPD, with mMRC scale 0-1, CAT score \<10, who had never experienced an exacerbation before or had a mild severity exacerbation once that not required hospitalization were considered as Group A. Patients were examined in three groups: Group 1 consisted of COPD patients not receiving treatment, Group 2 consisted of healthy volunteers for similar age and gender, and Group 3 consisted of COPD patients of the same age and gender with receiving Tiotropium 18 mcg Handihaler. A total of 108 patients, 36 patients in each group, were included in the study. Anterior chamber parameters, intraocular pressure values and photopic-mesopic pupil diameters were measured at the initial visit for Group 1 and Group 2 patients, and at the third month of treatment for Group 3 patients.
Anterior segment optical coherence tomography (AS-OCT) was used to measure anterior chamber and angle parameters, corneal topography was utilized to assess anterior chamber depth, pupil diameter measurements in mesopic and photopic conditions, and intraocular pressure (IOP) was calculated using Goldmann applanation tonometry. Each patient underwent a comprehensive ophthalmic evaluation, including testing of best-corrected visual acuity, slit-lamp biomicroscopy, and fundoscopic examination.
Corneal topography (Topcon Aladdin Corneal Topography, Japan) was used to evaluate anterior chamber depth and pupil diameter in mesopic and photopic conditions. Pupil diameters measured with corneal topography were obtained by the same researcher, using the same device, at the same times of day and under similar lighting conditions.
Intraocular pressure was measured using Goldman Applanation tonometry. All measurements were conducted by the same researcher around 10 a.m., using the same tonometer device, without any manipulation or negligible manipulation of the eyelids. Applanation was performed by rotating the dial on the Goldman tonometer previously set to 10 mm Hg. The procedure was repeated after one minute. If the difference between the first and second readings was greater than 2 mm Hg, a third reading was performed. The average of the data obtained from two readings was taken, and if a third reading was needed, the median was used instead.
This study is the first research that investigate the effects of Tiotropium on anterior chamber parameters, pupil diameters, and intraocular pressure in COPD treatment.
5,520 studies on the registry are indexed under Pulmonary Disease, Chronic Obstructive; 856 are open to participants now.
This study's enrollment of 108 is below the median of 158 across 1,497 observational studies indexed under Pulmonary Disease, Chronic Obstructive.
Browse Pulmonary Disease, Chronic Obstructive studies →Giresun University is the lead sponsor of 57 studies on the registry; 6 are open to participants now.
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Three groups were formed for the study. Group 1 consisted of COPD patients not receiving treatment, Group 2 consisted of healthy volunteers for similar age and gender, and Group 3 consisted of COPD patients of the same age and gender with receiving handhaler Tiotropium 18 mcg. Anterior chamber parameters, intraocular pressure values and photopic-mesopic pupil diameters were measured at the initial visit for Group 1 and Group 2 patients, and at the third month of treatment for Group 3 patients.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Group 1 consisted of COPD patients not receiving any treatment ( inhaled and/or systemic steroids, long-acting inhaled beta-2 agonists alone, theophylline and combined long-acting beta-2 agonists and long-acting anticholinergic ). These patients are early stage COPD patients.
Group 2 consisted of healthy volunteers for similar age and gender.
Group 3 consisted of COPD patients of the same age and gender with receiving only handhaler Tiotropium 18 mcg for three months.
Drug: Tiotropium
Tiotropium is a long-acting anticholinergic agent and has a bronchodilator effect. According to the COPD Gold 2024 guideline, it is one of the long-acting bronchodilator drugs used as the first choice in the treatment of group A COPD patients.
Tiotropium causes narrowing of the eye angles and an increase in intraocular pressure and pupil diameters.
Tiotropium 18 mcg is a long-acting anticholinergic drug used in the treatment of COPD. In patients diagnosed with COPD who do not receive any steroid treatment and who are not diagnosed with hypertension, glaucoma, diabetes mellitus, cataract and who have not undergone eye surgery and using only handhaler Tiotropium 18 microgram, a narrowing of the eye angles, an increase in photopic-mesopic pupil diameters and intraocular pressure were detected in the third month of treatment.
Time frame: Measurements were made in the third month of Tiotropium treatment.
Tiotropium did not cause acute angle-closure glaucoma in COPD patients.
Tiotropium 18 mcg is a long-acting anticholinergic drug used in the treatment of COPD. In patients diagnosed with COPD ( who do not receive any steroid treatment and who are not diagnosed with hypertension, glaucoma, diabetes mellitus, cataract and who have not undergone eye surgery ) using only handhaler Tiotropium 18 microgram, open angle-closure glaucoma was not observed.
Time frame: Measurements were made in the third month of Tiotropium treatment.
Ran from Oct 2023 to primary completion in Mar 2024, 5 months.
Of 466 non-industry observational studies under Pulmonary Disease, Chronic Obstructive, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 64. This study's 5 months is below that.
Counting every sponsor, half of 586 studies reached it within 26 months; a quarter within 14 and three quarters within 58.
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This study is completed, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.
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Giresun University