Vance Thompson MD Mitch Ibach OD

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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?

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

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?

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

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.

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

Risk of Placebo- G3 You Say:

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

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

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: .05 borderline .01 statistically significant .005 highly statistically significant. Guide’s Doctors Therapeutic Plans

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

Where is the Real Innovation? SMILE 110 eyes Both groups mean pre-op MRx -5.25 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), 1170-1178.

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.

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

Predictability at 12 Months

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. 2014 Mar;30(3):186-90. Caution: Investigational device. Limited by Federal Law to investigational use.

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. 2014 Feb;30(2):94-100. Caution: Investigational device. Limited by Federal Law to investigational use.

“There is Real Innovation with SMILE”

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

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

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

Mucin Response to Stimulation

Meibomium Response to Stimulation

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

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

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

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