Ignite Creation Date:
2024-10-25 @ 8:04 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06525051
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-07-21
Brief Title:
Effect of Tiotropium on Eye Findings in the Treatment of Chronic Obstructive Pulmonary Disease
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Examination of the Effect of Handhaler Tiotropium a Long-acting Anticholinergic on Anterior Chamber Parameters
Status:
COMPLETED
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study aimed to examine the effect of Tiotropium which is used in the treatment of COPD on eye symptomsThe 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
Detailed Description:
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 2023180 and 910202302 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 am 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
The study was conducted prospectively between October 2023 and April 2024 after obtaining local Ethics Committee approval Giresun EAH KEAK 2023180 and 910202302 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 am 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None