Ignite Creation Date:
2024-05-05 @ 9:31 PM
Last Modification Date:
2024-10-26 @ 10:05 AM
Study NCT ID:
NCT00906087
Status:
COMPLETED
Last Update Posted:
2017-06-02
First Post:
2009-05-19
Brief Title:
Effect of Myocilin Genetic Variants on Intraocular Pressure and Pressure Variation in Sitting and Supine Positions
Sponsor:
University of Michigan
Organization:
University of Michigan
Study Overview
Official Title:
The Effect of Myocilin Genetic Variants on Intraocular Pressure and Blood Pressure Variation in Sitting and Supine Positions
Status:
COMPLETED
Status Verified Date:
2017-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Myoc Gene
Brief Summary:
The purpose of this study is to determine if one of the genes that can cause glaucoma called myocilin are associated with larger eye pressure and blood pressure changes in sitting and lying down positions without glaucoma drug treatment and with glaucoma drug treatment with a combination medication called Cosopt Merck Co Inc
Detailed Description:
Glaucoma is an important public health issue and identifying new markers to improve treatment outcomes is a high priority Progress in Mendelian genetic approaches has led to identifying 15 genes and 31 loci httpwwwncbinlmnihgov however since these monogenic forms of glaucoma are uncommon other approaches are needed to identify genetic markers that contribute to common risk factors such as elevated eye pressure eye pressure fluctuation and drug response variation
It is well known that eye pressure varies over a 24-hour period1-6 but the mechanisms that regulate this eye pressure rhythm are not yet fully known Drance reported that 84 of normal eyes N320 eyes had eye pressure fluctuations of less than 5 mmHg in contrast to only 6 of untreated glaucomatous eyes N1387 Drance clearly recognized that eye pressure factors were more variable in eyes with glaucoma Attention to this eye pressure fluctuation during glaucoma treatment is important because fluctuation leads to progression The variation in eye pressure drug response profiles measured at selected times over a 24-hour period is related to the mechanism of action of these drugs endogenous circadian rhythms and glaucoma The molecular and genetic tools are now available to identify potential genetic markers for these variable traits
Advancing clinical research to the translational level is an important step to integrate our ever increasing knowledge base in genomics and proteinomics with clinical trials and clinical studies Given the infrastructure at the University of Michigan with the strength in both glaucoma genetics and our resources in the clinic it is possible to test for relationships between glaucoma genes and eye pressure Although it is known that myocilin MYOC mutations cause the phenotype of high pressure open-angle glaucoma the effect of these MYOC mutations in pre-symptomatic subjects and patients with early open-angle glaucoma on eye pressure variation is not known
It is well known that eye pressure varies over a 24-hour period1-6 but the mechanisms that regulate this eye pressure rhythm are not yet fully known Drance reported that 84 of normal eyes N320 eyes had eye pressure fluctuations of less than 5 mmHg in contrast to only 6 of untreated glaucomatous eyes N1387 Drance clearly recognized that eye pressure factors were more variable in eyes with glaucoma Attention to this eye pressure fluctuation during glaucoma treatment is important because fluctuation leads to progression The variation in eye pressure drug response profiles measured at selected times over a 24-hour period is related to the mechanism of action of these drugs endogenous circadian rhythms and glaucoma The molecular and genetic tools are now available to identify potential genetic markers for these variable traits
Advancing clinical research to the translational level is an important step to integrate our ever increasing knowledge base in genomics and proteinomics with clinical trials and clinical studies Given the infrastructure at the University of Michigan with the strength in both glaucoma genetics and our resources in the clinic it is possible to test for relationships between glaucoma genes and eye pressure Although it is known that myocilin MYOC mutations cause the phenotype of high pressure open-angle glaucoma the effect of these MYOC mutations in pre-symptomatic subjects and patients with early open-angle glaucoma on eye pressure variation is not known
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| Merck IISP31911 | OTHER_GRANT | Merck | None |