Onchocerciasis Clinical Trial
Official title:
Microfilarial Clearance From the Eye and Ocular Changes Associated With Ivermectin Treatment in Individuals With Onchocerciasis
Verified date | December 2020 |
Source | Washington University School of Medicine |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The DOLF Ocular Changes after Ivermectin study will investigate the kinetics of O. volvulus microfilaria (Mf) in the eye following treatment with ivermectin. The primary objective is to determine the proportion of participants with complete Mf clearance from the eye at 3 and 6 months following treatment with ivermectin (IVM).
Status | Completed |
Enrollment | 231 |
Est. completion date | August 23, 2019 |
Est. primary completion date | August 23, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 16 Years to 70 Years |
Eligibility | Inclusion Criteria: - Have at least 1 palpable subcutaneous nodule (onchocercoma) and = 1 Mf/mg of skin (by skin snip) Exclusion Criteria: - Pregnancy and breastfeeding mothers within 1 month of giving birth - Have base line eye diseases including glaucoma, uveitis, severe keratitis, and/or cataracts that interfere with visualization of the posterior segment of the eye. - Prior allergic / hypersensitivity reactions or intolerance to ivermectin - Treatment with ivermectin in the past 6 (six) months |
Country | Name | City | State |
---|---|---|---|
Ghana | University of Health and Allied Sciences | Hohoe |
Lead Sponsor | Collaborator |
---|---|
Washington University School of Medicine | Case Western Reserve University, University of Health and Allied Sciences |
Ghana,
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* Note: There are 42 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Assess the utility of optical coherence tomography for evaluating the presence and clearance of Mf in the anterior and posterior segments of the eye. | Results from the optical coherence tomography (OCT) will be compared with slit lamp and other ocular examinations | baseline, 3 and 6 months following treatment | |
Other | Evaluate ocular changes between baseline and 3 months following ivermectin treatment using OCT | Results from the optical coherence tomography (OCT) will be compared in participants pre and post treatment | baseline, and 3 months following treatment | |
Other | Evaluate ocular changes between baseline and 6 months following ivermectin treatment using OCT | Results from the optical coherence tomography (OCT) will be compared in participants pre and post treatment | baseline, and 6 months following treatment | |
Primary | Number of participants with complete microfilaria clearance from the eye at 3 months | Microfilaria in the anterior chamber of the eye will be counted during slit lamp examination at time of assessment. Participants without Mf in the eye will be considered clear of infection in the eye. | 3 months following treatment | |
Primary | Number of participants with complete microfilaria clearance from the eye at 6 months | Microfilaria in the anterior chamber of the eye will be counted during slit lamp examination at time of assessment. Participants without Mf in the eye will be considered clear of infection in the eye. | 6 months following treatment | |
Secondary | The change from baseline in the number of microfilaria detected in the skin at 3 months | Microfilaria (Mf) in the skin will be detected by skin snip microscopy. Up to four (4) skin snips using a corneoscleral punch will be weighed on an analytical balance and incubated for at least 8 hours in isotonic saline in a well of a flat-bottomed microtitre plate at ambient temperature. The Mf that have emerged will be counted using a microscope. Mf number and skin snip weight will be recorded. The mean skin microfilarial density will be calculated and recorded as mf/mg. | baseline, and 3 months following treatment | |
Secondary | The change from baseline in the number of microfilaria detected in the skin at 6 months | Microfilaria (Mf) in the skin will be detected by skin snip microscopy. Up to four (4) skin snips using a corneoscleral punch will be weighed on an analytical balance and incubated for at least 8 hours in isotonic saline in a well of a flat-bottomed microtitre plate at ambient temperature. The Mf that have emerged will be counted using a microscope. Mf number and skin snip weight will be recorded. The mean skin microfilarial density will be calculated and recorded as mf/mg. | baseline, and 6 months following treatment | |
Secondary | The change from baseline in the number of microfilaria detected in the eye at 3 months | Microfilaria in the anterior chamber of the eye will be counted during slit lamp examination at time of assessment. | baseline, 3 months following treatment | |
Secondary | The change from baseline in the number of microfilaria detected in the eye at 6 months | Microfilaria in the anterior chamber of the eye will be counted during slit lamp examination at time of assessment. | baseline, 6 months following treatment | |
Secondary | Number of participants with complete microfilaria clearance from the skin at 3 months | Microfilaria (Mf) in the skin will be detected by skin snip microscopy. Up to four (4) skin snips using a corneoscleral punch will be weighed on an analytical balance and incubated for at least 8 hours in isotonic saline in a well of a flat-bottomed microtitre plate at ambient temperature. The Mf that have emerged will be counted using a microscope. Mf number and skin snip weight will be recorded. Participants without Mf in the skin will be considered clear of infection in the skin. | 3 months following treatment | |
Secondary | Number of participants with complete microfilaria clearance from the skin at 6 months | Microfilaria (Mf) in the skin will be detected by skin snip microscopy. Up to four (4) skin snips using a corneoscleral punch will be weighed on an analytical balance and incubated for at least 8 hours in isotonic saline in a well of a flat-bottomed microtitre plate at ambient temperature. The Mf that have emerged will be counted using a microscope. Mf number and skin snip weight will be recorded. Participants without Mf in the skin will be considered clear of infection in the skin. | 6 months following treatment |
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