We are beginning the next phase of this journey. There is a lot that will happen over a very short amount of time.
An Orientation and Mobility Assessor will be flying out tonight from Philadelphia and will be spending some time tomorrow with Nomi. She will observe Nomi at home, and record her observations. She will be focusing on how he has adapted to home life with his disability. This will last a few hours.
Then, its off to Philadelphia for our baseline screening. The baseline screening incorporates all of the tests that were performed previously at our initial visit, along with some new tests as well. These tests will be spread out over 4 days.
The older tests included : blood work, dark adapt test, mobility testing, visual acuity testing, Goldman visual field exam, Humphrey visual field exam, dilation with slit lamp/IOP exam and fundus exam, optical coherence tomography (two types Ziess stratus and Heidelberg Spectralis) and fundus photography.
The new tests will include: more comprehensive blood work, physical exam, visual function questionnaires, pupillometry, contrast sensitivity, full field light sensitivity threshold, cycloplegic refraction, and tear and urine collection.
Some of these tests will be preformed twice, with and without the eyes dilated.
Hopefully soon I will be able to get everyone a more thorough explanation of what each test is and what the results mean. I am still learning, and as I know more I will share.
At the end of the 4th day, we find out if Nomi is in group 1 or group 2. This is a random selection...
2/3 of all patients will fall into group 1, the immediate intervention group.
Group 1 patients will get scheduled to have their procedure done immediately, within 30 days of the baseline screening.
The first eye is then injected... and there is a post op follow up days 1 and 3 after the injection. The second eye has to be injected 6 to 18 days after the first eye, with post ops again days 1 and 3 after injection. Nomi is not allow to fly 7 days following an injection, and if for any reason, if the second eye is not treated within 18 days of the first, then it can't be treated.
There is a series of follow ups after the injections... specifically after the second eye...
Day 14, day 30, day 90, day 180, and day 365 of year 1, and then yearly after that for the next 4 years...
At each of these follow ups, all the same tests that were preformed at the baseline screening will be performed again. For the following 10 years, the researchers will follow up via either phone, or in person again, but testing will not be needed.
This timeline can change if for any reason Nomaan has an adverse reaction to the procedure, or experiences anything out of the ordinary at any time with his vision...
The remaining 1/3 of the patients will be assigned to group 2, the control group. These patients will be treated, but must wait 12 months until they have the procedure. The procedural and follow up timeline mimics that of group 1, except, during the 12 month waiting period, the patients have to have 4 additional baselines done on day 30, day 90, day 180, and day 365 after the initial baseline.
Obviously, we are hopeful to fall into group 1. As parents, we want the procedure as soon as possible. Results are usually seen quickly within 7 days of treatment, and we are excited to see how Nomi will benefit. Waiting 12 months, though disappointing, is not a disaster. Nomi will still be treated, we just need to be a little more patient... we have been waiting more than 2 years already, we can wait a little longer if need be. Either way, the end result is the same, Nomi receives the ground breaking treatment, and his life changes.
An Orientation and Mobility Assessor will be flying out tonight from Philadelphia and will be spending some time tomorrow with Nomi. She will observe Nomi at home, and record her observations. She will be focusing on how he has adapted to home life with his disability. This will last a few hours.
Then, its off to Philadelphia for our baseline screening. The baseline screening incorporates all of the tests that were performed previously at our initial visit, along with some new tests as well. These tests will be spread out over 4 days.
The older tests included : blood work, dark adapt test, mobility testing, visual acuity testing, Goldman visual field exam, Humphrey visual field exam, dilation with slit lamp/IOP exam and fundus exam, optical coherence tomography (two types Ziess stratus and Heidelberg Spectralis) and fundus photography.
The new tests will include: more comprehensive blood work, physical exam, visual function questionnaires, pupillometry, contrast sensitivity, full field light sensitivity threshold, cycloplegic refraction, and tear and urine collection.
Some of these tests will be preformed twice, with and without the eyes dilated.
Hopefully soon I will be able to get everyone a more thorough explanation of what each test is and what the results mean. I am still learning, and as I know more I will share.
At the end of the 4th day, we find out if Nomi is in group 1 or group 2. This is a random selection...
2/3 of all patients will fall into group 1, the immediate intervention group.
Group 1 patients will get scheduled to have their procedure done immediately, within 30 days of the baseline screening.
The first eye is then injected... and there is a post op follow up days 1 and 3 after the injection. The second eye has to be injected 6 to 18 days after the first eye, with post ops again days 1 and 3 after injection. Nomi is not allow to fly 7 days following an injection, and if for any reason, if the second eye is not treated within 18 days of the first, then it can't be treated.
There is a series of follow ups after the injections... specifically after the second eye...
Day 14, day 30, day 90, day 180, and day 365 of year 1, and then yearly after that for the next 4 years...
At each of these follow ups, all the same tests that were preformed at the baseline screening will be performed again. For the following 10 years, the researchers will follow up via either phone, or in person again, but testing will not be needed.
This timeline can change if for any reason Nomaan has an adverse reaction to the procedure, or experiences anything out of the ordinary at any time with his vision...
The remaining 1/3 of the patients will be assigned to group 2, the control group. These patients will be treated, but must wait 12 months until they have the procedure. The procedural and follow up timeline mimics that of group 1, except, during the 12 month waiting period, the patients have to have 4 additional baselines done on day 30, day 90, day 180, and day 365 after the initial baseline.
Obviously, we are hopeful to fall into group 1. As parents, we want the procedure as soon as possible. Results are usually seen quickly within 7 days of treatment, and we are excited to see how Nomi will benefit. Waiting 12 months, though disappointing, is not a disaster. Nomi will still be treated, we just need to be a little more patient... we have been waiting more than 2 years already, we can wait a little longer if need be. Either way, the end result is the same, Nomi receives the ground breaking treatment, and his life changes.
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