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| Name | Class |
|---|---|
| Case Western Reserve University | OTHER |
| University of Health and Allied Sciences | OTHER |
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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).
This study will examine the kinetics of Mf clearance in the eye following ivermectin treatment. Previous studies have been unable to fully assess clearance Mf from the posterior chamber of the eye. This study will be the first to use optical coherence tomography (OCT) in patients with onchocerciasis to document parasites and pathology in the anterior and posterior chambers of the eye, and assess ocular changes following standard ivermectin treatment.
This will be a biomedical prospective cohort study.
The cohort will be stratified based on Mf levels to achieve approximately the following distribution of individuals with roughly one-third of participants in each group.
All participants recruited into the study will be treated with a single dose of ivermectin (150 ug/kg) by mouth under direct observation. This is the standard of care for treatment with onchocerciasis.
Participants will be evaluated following treatment with detailed parasitological and ocular examinations 7 days, 3 months and 6 months after treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ivermectin | Experimental | Single dose directly observed treatment with Ivermectin 3Mg Tab (150 ug/kg) delivered orally. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ivermectin 3Mg Tab | Drug | ivermectin tablet |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Evaluate ocular changes between baseline and 3 months following ivermectin treatment using OCT |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gary Weil, MD | Washington University School of Medicine | Principal Investigator |
| Christopher King, MD PhD | Case Western Reserve University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Health and Allied Sciences | Hohoe | Ghana |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28771480 | Background | Herricks JR, Hotez PJ, Wanga V, Coffeng LE, Haagsma JA, Basanez MG, Buckle G, Budke CM, Carabin H, Fevre EM, Furst T, Halasa YA, King CH, Murdoch ME, Ramaiah KD, Shepard DS, Stolk WA, Undurraga EA, Stanaway JD, Naghavi M, Murray CJL. The global burden of disease study 2013: What does it mean for the NTDs? PLoS Negl Trop Dis. 2017 Aug 3;11(8):e0005424. doi: 10.1371/journal.pntd.0005424. eCollection 2017 Aug. No abstract available. | |
| 27801998 |
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Datasets used for published results will be shared publically through a journal or other open source data repository so that the broader scientific community can access it. Only de-identified data will be shared publicly.
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| ID | Term |
|---|---|
| D009855 | Onchocerciasis |
| ID | Term |
|---|---|
| D005368 | Filariasis |
| D017205 | Spirurida Infections |
| D017190 | Secernentea Infections |
| D009349 | Nematode Infections |
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| ID | Term |
|---|---|
| D007559 | Ivermectin |
| ID | Term |
|---|---|
| D018942 | Macrolides |
| D061065 | Polyketides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
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Participants are all given a standard treatment (ivermectin) for onchocerciasis.
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| baseline, and 3 months following treatment |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
Results from the optical coherence tomography (OCT) will be compared in participants pre and post treatment |
| baseline, and 3 months following treatment |
| 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 |
| Background |
| Progress report on the elimination of human onchocerciasis, 2015-2016. Wkly Epidemiol Rec. 2016 Oct 28;91(43):505-14. No abstract available. English, French. |
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| D006373 |
| Helminthiasis |
| D010272 | Parasitic Diseases |
| D007239 | Infections |
| D012876 | Skin Diseases, Parasitic |
| D012874 | Skin Diseases, Infectious |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |