Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04631978
Other study ID # 19102017-15/4-184
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 1, 2020
Est. completion date August 30, 2020

Study information

Verified date November 2020
Source Akdeniz University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Cachectic patients and controls undergoing a comprehensive ophthalmologic examination. The imaging of all subjects is undertaken using a commercial OCTA device with a scan rate of 70,000 A-scans/s, scan beam wavelength of 840 ± 10 nm and bandwidth of 45 nm. All measurements are performed between 10:00 and 12:00 on the same day. The OCTA images are independently graded and assessed by two retinal specialists. The software automatically segmented these full-thickness retinal scans into the superficial and deep inner retinal vascular plexuses, outer retina, and choriocapillaris (CC). The vascular density in the superficial and deep retinal vascular zones is calculated automatically by the software, and the foveal avascular zone (FAZ) and foveal density (FD) are also automatically determined. Choroidal thickness is calculated manually by two retinal specialists, and the average value was used.


Description:

Cachectic patients and controls undergoing a comprehensive ophthalmologic examination, including the measurements of best-corrected visual acuity (BCVA), refractive error (KR-8900; Topcon, Tokyo, Japan), intraocular pressure (IOP, Full Auto Tonometer TX-F; Topcon), axial length (AL, Lenstar LS 900, Haag-Streit AG, Switzerland), slit lamp examination of the anterior segment, dilated fundus examination, and OCTA imaging (Optovue RTVue XR 100 Avanti, Freemont, California, USA) are included in the study. To calculate BMI, height is measured using a standard anthropometric tape (Bioplus Stature Meter, model number IND/09/2005/815), and a certified electronic weighing scale (model number Omron HN-283) is used to measure weight. According to the national guidelines, the patients are classified into two underweight groups: Group 1 consisting of those with a BMI of <17.00 kg/m2 and Group 2 comprising those with a BMI of 17.00 to 18.49 kg/m2. The control group is formed with individuals with a normal BMI (18.50 to 24.99 kg/m2). The right eye of each participant is included in the study. If the right eye meets any of the exclusion criteria, then the left eye is selected for the sample. The inclusion criteria for the patient group is being underweight (BMI < 18.50 kg/m2). The exclusion criteria for all groups are as follows: refractive error >+3.0 diopters (D) or <-3.0 D spherical equivalent; poor image quality <60 due to unstable fixation; IOP > 21 mm Hg; longer AL (>25 mm); pre-existing ophthalmic pathologies; prior ocular surgery; and a systemic chronic disease that can cause underweight or retinopathy, such as cancer, malnutrition, and diabetes mellitus. OCTA The imaging of all subjects is undertaken using a commercial OCTA device with a scan rate of 70,000 A-scans/s, scan beam wavelength of 840 ± 10 nm and bandwidth of 45 nm. This device can perform 70 000 A-scans/s per second to acquire volumes of 304 × 304 A-scans. All measurements are performed between 10:00 and 12:00 on the same day. To evaluate the vascular structures, 6×6 mm OCTA software is used. The split-spectrum amplitude decorrelation angiography (SSADA) algorithm is performed in all participants. The images of poor quality (signal strength index (SSI) < 8) with either significant motion artifact or incorrect segmentation are excluded. The OCTA images are independently graded and assessed by two retinal specialists. The software automatically segmented these full-thickness retinal scans into the superficial and deep inner retinal vascular plexuses, outer retina, and choriocapillaris (CC). The vascular density in the superficial and deep retinal vascular zones is calculated automatically by the software, and the foveal avascular zone (FAZ) and foveal density (FD) are also automatically determined. The same software also calculates the flow index rates in a central circular zone of 3.144 mm² in the outer retina and CC segments. Choroidal thickness is calculated manually by two retinal specialists, and the average value was used.


Recruitment information / eligibility

Status Completed
Enrollment 48
Est. completion date August 30, 2020
Est. primary completion date August 30, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 40 Years
Eligibility Inclusion Criteria: - Underweight (BMI < 18.50 kg/m2). Exclusion Criteria: - refractive error >+3.0 diopters (D) or <-3.0 D spherical equivalent; - poor image quality <60 due to unstable fixation - IOP > 21 mm Hg - longer AL (>25 mm) - pre-existing ophthalmic pathologies - prior ocular surgery - a systemic chronic disease that can cause underweight or retinopathy, such as cancer, malnutrition, and diabetes mellitus.

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
Comprehensive ophthalmologic examination
Measurements of best-corrected visual acuity, refractive error, intraocular pressure, axial length, slit lamp examination of the anterior segment, dilated fundus examination, and optical coherence tomography angiography imaging.

Locations

Country Name City State
Turkey Asli Çentinkaya Yaprak Antalya

Sponsors (1)

Lead Sponsor Collaborator
Akdeniz University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Choriocapillaris flow area Choriocapillaris flow area assessed with optical coherence tomography angiography 10 minutes
Secondary Subfoveal choroidal thickness Subfoveal choroidal thickness assessed with optical coherence tomography angiography 10 minutes
Secondary Vessel density Vessel density assessed with optical coherence tomography angiography 10 minutes
Secondary Foveal avascular zone Foveal avascular zone assessed with optical coherence tomography angiography 10 minutes
Secondary Subfoveal central macular thickness Subfoveal central macular thickness assessed with optical coherence tomography angiography 10 minutes
See also
  Status Clinical Trial Phase
Recruiting NCT05603585 - Optimal Protein Supplementation and Early Exercise In Mechanically Ventilated Patients N/A
Recruiting NCT06206785 - Resting Energy Expenditure in Palliative Cancer Patients
Enrolling by invitation NCT05028192 - Mitochondria Preservation by Exercise Training: a Targeted Therapy for Cancer and Chemotherapy-induced Cachexia
Completed NCT01696604 - A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of GSK2849466 in Healthy Male Subjects Phase 1
Recruiting NCT04627376 - Multimodal Program for Cancer Related Cachexia Prevention N/A
Completed NCT02567773 - Safety, Tolerability, Pharmacokinetic (PK), and Pharmacodynamic Study of GSK2881078 and Study to Evaluate the Effect of CYP3A4 Inhibition on PK of GSK2881078 Phase 1
Completed NCT00866970 - Safety, Efficacy and Pharmacokinetics of ALD518 in Patients With Non-Small Cell Lung Cancer-related Fatigue and Cachexia Phase 2
Active, not recruiting NCT00710632 - Screening to Predict Weight Loss in Patients With Cancer N/A
Completed NCT00031785 - Megestrol in Treating Patients Who Are Undergoing Radiation Therapy for Lung Cancer Phase 3
Withdrawn NCT02017925 - Pulmonary Rehabilitation in Improving Lung Function in Patients With Locally Advanced Non-Small Cell Lung Cancer Undergoing Chemoradiation N/A
Recruiting NCT01829880 - Impact of Body Composition on Bisoprolol and Ramipril Pharmacokinetics in Patients With Chronic Heart Failure N/A
Completed NCT01419145 - A Feasibility Study of Multimodal Exercise/Nutrition/Anti-inflammatory Treatment for Cachexia - the Pre-MENAC Study N/A
Completed NCT01692990 - Study on the Effect of Fish Oil and Appetite Phase 0
Terminated NCT00962234 - Metabolism of Lipids in Advanced Cancer N/A
Terminated NCT00851448 - Safety, Tolerance and Efficacy of an Oral Nutritional Supplement in Lung Cancer Patients N/A
Completed NCT00994669 - Development of a Non-invasive Assessment of Skeletal Muscle Loss in Cancer Patients N/A
Completed NCT01015274 - Non-invasive Assessment of Skeletal Muscle Loss in Cancer Patients
Completed NCT00972634 - Computerized Questionnaires in Assessing Symptoms, Pain, Depression, and Physical Function in Patients With Metastatic and/or Advanced Locoregional Cancer N/A
Terminated NCT00558558 - Haelan and Nutrition in Cancer Patients Phase 2
Terminated NCT00535015 - Safety and Efficacy Study of Betamarc to Treat Loss of Weight and Appetite in Non-Small Cell Lung Cancer Phase 2