1. Vance Thompson MD
Mitch Ibach OD

2. Research No Search A Case for Research This is research vs. No Search.
A debate of the pro’s and con’s of research and should we be doing it.
Dr. Thompson will argue for research and I will argue against.
A Case for Research

3. Why Do We Do Research? Implantable or invasive procedures on patients
Risk of Placebo
Where is the real innovation
Travel
The main four reasons why I disagree with research all revolve around the patient.
Remember these are human trials, not research with this cute little guy. I am attempting to beat Dr. Thompson at his own game by having cute animal pictures to tug on emotions

4. Patient’s Deserve To Know
Research No
Search
Patient’s Deserve To Know

5. Patient’s Deserve To Know
Radial Keratotomy
PRK
Patient’s Deserve To Know

6. Patient’s Deserve To Know
PRK
LASIK
Patient’s Deserve To Know

7. Patient’s Deserve To Know
LASIK
Phakic IOLs
Patient’s Deserve To Know

8. Patient’s Deserve To Know
SMILE
LASIK
Patient’s Deserve To Know

9. Patient’s Deserve To Know
Traditional Cataract Surgery
Femtosecond
Laser
(ReLACS)
Patient’s Deserve To Know

10. Patient’s Deserve To Know
One Way
Another
Way
Patient’s Deserve To Know

11. Patient’s Deserve To Know
Another
Way
True
Advancement?
Patient’s Deserve To Know

12. Patient’s Deserve To Know
Data
Other
Way
True
Advancement
Patient’s Deserve To Know

13. Patient’s Deserve To Know
Quality Clinical Trials
Other
Way
True
Advancement
Patient’s Deserve To Know

14. Patient’s Deserve To Know
Prospective, Randomized
Clinical Trials
Other
Way
True
Advancement
Patient’s Deserve To Know

15. Patient’s Deserve To Know
Prospective, Randomized
Clinical Trials
Other
Way
True
Advancement
Patient’s Deserve To Know

16. Implantable Devices- Calhoun LAL
The RISK it doesn’t work?
What if the lens material reacts inside the eye?
Extended inflammation or glare/halo’s
Multiple devices, formulas and methods for predicting IOL power, NEED?
Once it is implanted into the eye, is it too late?
In our clinic we have Topography, Itrace, Lenstarr, Intra-operative Aberrometry, why do we need a lens that changes refractive power inside the eye?
Why put human subjects at risk

17. Implantable Devices- Calhoun LAL
You Say:
Implantable Devices- Calhoun LAL
The RISK it doesn’t work?
What if the lens material reacts inside the eye?
Extended inflammation or glare/halo’s
Multiple devices, formulas and methods for predicting IOL power, NEED?

18. Implantable Devices- Calhoun LAL
The RISK it doesn’t work?
What if the lens material reacts inside the eye?
Extended inflammation or glare/halo’s

19. Implantable Devices- Calhoun LAL
You Say:
Implantable Devices- Calhoun LAL
Healing
Incision
Effective Lens Position
The RISK it doesn’t work?
What if the lens material reacts inside the eye?
Extended inflammation or glare/halo’s
Multiple devices, formulas and methods for predicting IOL power, NEED?

20. Calhoun LAL Subtracting Power from the Lens Adding Power to the Lens
Correcting Astigmatism
Caution: Investigational device. Limited by Federal Law to investigational use.

21. Risk of Placebo- G3
-I wanted to look at two different trials with glaucoma and cataract surgery that involve placebo
-In a prospective trial where patients sign an informed consent there is often a placebo or control arm that doesn’t get treatment.
- There is currently a study for a newer glaucoma stent in combination that has a placebo or control arm Isn’t the risk to much for patients.

22. Patient’s Deserve To Know
Prospective, Randomized
Clinical Trials
Other
Way
True
Advancement
Patient’s Deserve To Know

23. Risk of Placebo- G3
You Say:

24. Patient’s Deserve To Know
Prospective, Randomized
Clinical Trials
Other
Way
True
Advancement
Patient’s Deserve To Know

25. Patient’s Deserve To Know
Prospective, Randomized
Clinical Trials
Other
Way
True
Advancement
Patient’s Deserve To Know

26. Guide’s Doctors Therapeutic Plans
Prospective, Randomized
Clinical Trials
Other
Way
Proper Oversight:
Food and Drug Administration
Institutional Review Board
True
Advancement
statistical significance
p-value: borderline
.01 statistically significant
.005 highly statistically significant.
Guide’s Doctors Therapeutic Plans

27. Risk of Placebo- G3 Risk is Controlled: Patient safety comes first
Study comes second
Doctor judgement

28. Where is the Real Innovation? SMILE
110 eyes
Both groups mean pre-op MRx sph with 1.00D cyl
Neither group had significantly increased HOA’s (Avg. Pre-op 0.35)
No intra- or postoperative flap complications either group
Where is the real Innovation. Is this research for the NEXT big Thing, or are we just trying to invent a better wheel
This is a 2014 articles in Ophth– Comparing wavefront guided Lasik vs Wavefront optimized Lasik.
With Lasik Results this good. We have PRK, Implantable collamer or contact lenses and refractive lens exchanges,
Why experiment with a new procedure?
He, L., Liu, A., & Manche, E. (2014, June). Wavefront-Guided Versus Wavefront-Optimized Laser in situ Keratomileusis for Patients With Myopia: A Prospective Randomized Contralateral Eye Study. American Journal of Ophthalmology,157(6),

29. Where is the Real Innovation- SMILE?
Is SMILE real innovation  Or just Alphagan becoming Alphagan P with re-branding and re-marketing.
Does SMILE warrant the money, research work, and patient risk, or is what we have already good enough.

30. “There is Real Innovation with SMILE”
I Say:
“There is Real Innovation with SMILE” 

31. Predictability at 12 Months

32. Dry eye after small incision lenticule extraction and LASIK for myopia
Dry eye after small incision lenticule extraction and LASIK for myopia. Xu Y, Yang Y. J Refract Surg Mar;30(3):
Caution: Investigational device. Limited by Federal Law to investigational use.

33. Comparison of corneal sensation between small incision lenticule extraction (SMILE) and femtosecond laser-assisted LASIK for myopia.
Li M, Zhou Z, Shen Y, Knorz MC, et al. J Refract Surg Feb;30(2):
Caution: Investigational device. Limited by Federal Law to investigational use.

34. “There is Real Innovation with SMILE”

35. Travel-Oculeve
Most trials have 4-9 follow-ups over 3 weeks to 2 years. Oculeve Trial 6-8 follow-ups to check progress and repeat tests.
If Implantable devices in humans, Risk of placebo, and question of real innovation aren’t enough--> These patients all have to have multiple traveling appointments to make these research appointments.
 Most trials, then say” Oculeve is a device to stimulate tear production, in this trial
That can be as labile as dry eye syndrome.
This is a picture outise of my office on a day I saw research patients

36. Oculeve: The First Ophthalmic Electroceutical
Disposable Tip with Hydrogel
Handheld Unit
Caution: Investigational device. Limited by Federal Law to investigational use.

37. Immediate Response to Stimulation
Increase:
Schirmer Score
Mucin
Meibum
Tear Chemistry Analysis Showing
all Three Layers in Stimulated Tear

38. Mucin Response to Stimulation

39. Meibomium Response to Stimulation

40. Travel-Oculeve
Most trials have 4-9 follow-ups over 3 weeks to 2 years. Oculeve Trial 6-8 follow-ups to check progress and repeat tests.
If Implantable devices in humans, Risk of placebo, and question of real innovation aren’t enough--> These patients all have to have multiple traveling appointments to make these research appointments.
 Most trials, then say” Oculeve is a device to stimulate tear production, in this trial
That can be as labile as dry eye syndrome.
This is a picture outise of my office on a day I saw research patients

41. Research No Search A Case for Research This is research vs. No Search.
A debate of the pro’s and con’s of research and should we be doing it.
Dr. Thompson will argue for research and I will argue against.
A Case for Research

42. X Research No Search A Case for Research
This is research vs. No Search.
A debate of the pro’s and con’s of research and should we be doing it.
Dr. Thompson will argue for research and I will argue against.
A Case for Research