Ocular Disease III: Exam 2: Lecture 6-7: Diabetic Retinopathy 2

Question 1

High Risk PDR Characteristics

1. Risk of Severe Vision Loss (

Answer 1

1. b. 26%
   c. 4%
2. a. 26%
   b. 9%
3. a. 37%
   b. 20%
4. a. 30%
   b. 7%

Question 2

How do you Treat High Risk PDR?

Panretinal Photocoagulation (PRP) for PDR

1. What kind of Laser is used?
2. How many burns/Eye over 3 SESSIONS?
   a. The Amt of Tx during any one Session is governed by what?
   b. Spot Size is what?
   c. Duration of BURN time?
   d. Power of Laser is ENOUGH to Stimulate the RPE to do what?

Answer 2

1. Argon Blue-Green Laser
2. 1500-2500 Burns/Eye over 3 Sessions
   a. by Pt threshold for pain and ability to maintain Concentration
   b. 100-500 microns
   c. 0.1-0.2 sec
   d. to Ablate the retina

Question 3

PRP (2)

1. It can be applied up to how close to around the Fovea?
2. Grid Laser up to how many microns from the fovea?
3. Focal laser where?

Answer 3

1. up to 2 DD around the Fovea
2. 500 microns from the Fovea
3. Focal laser 50 micron spot for 0.1 Sec Exposure Time w/in 500 Microns of Fovea
   * Focal laser is 10x’s Smaller than Grid Laser…(used for MICROANEURYSMS!!)

Question 4

PRP (3)

1. What does it DESTROY?
2. What does it Reduce?
3. May cause THINNING of what Retinal Layers?
   a. This allows Choroidal Blood and O2 to reach what Retinal Layers?
4. Can Cause Regression of what?
5. Reduces RISK of SEVERE VISION LOSS by what %?
6. When should you DO PRP Promptly?!

Answer 4

1. HYPOXIC RETINA (destroys ischemic area and Amt of Angiogenesis Factors Released)
2. Vasoproliferative Stimuli
3. of Outer Retinal Layers
   a. the Inner Retinal Layers
4. NEO Regression
5. by 50%
6. for EYES w/HIGH RISK CHARACTERISTICS and NVI

Question 5

PRP: Mechanism: Unknown: But he thinks it works like this…

1. Basically, you are BBQing the Fundus to prevent what?
2. Causes Destruction of what?
   a. What is the Black stuff after doing PRP?
3. Leads to Decrease demand of what molecule?
4. Get Regression of what?

Answer 5

1. Proliferation of new BVs (avoid Macula, posterior pole, disc)
2. of RPE
   a. Hyperplasia
3. of O2
4. of Blood Vessels

Question 6

PRP Complications

1. If you have Worsening Macular Edema and Pucker (So CSME and DR): What will they DO FIRST?
2. Major Complications? (5)
   a. Severe reduction in what?
   b. What happens to Night vision and color?
   c. What about dark adaptability (is it affected)
   d. Central vision affected?
   e. What about pupil?

Answer 6

1. They will do FOCAL LASER First for CSME (macular laser) then they’ll do PRP!
2. a. Severe Field Reduction
   b. Impaired Color/Night Vision
   c. Decreased Dark Adaptability
   d. Mild Decrease in Central Vision (14%)
   e. Residual dilated pupil & Accommodative Paresis due to Lasering the Ciliary Nerves

Question 7

PRP Complications (2)

1. Burns on what 2 things?
   a. How does this work?
2. What can happen from Treating NEO DIRECTLY?
3. What TRACTION can develop?
4. If you use TOO HEAVY of a Laser, what will happen? (2)
5. What can happen from ANTERIOR ROTATION of the CB? (Malignant GIc)
6. What can form from EXCESSIVE Tx?

Answer 7

1. Foveal and Disc Burns
   a. Pt moves eye during procedure; Doctor gets lost during Tx; Can be prevented by using a temporal barrier of burns.
2. Hemorrhage
3. Vitreoretinal Traction
4. Choroidal Detachment and 2ndary Exudative RD
5. Angle Closure
6. CNVM

Question 8

PDR

1. WHAT is the GOLD STANDARD still?

Answer 8

1. PRP (came up in the 60s/70s, nothing is better)
   * Know the Difference b/w FOCAL (20 seconds and you’re done) and PRP
   * Reduces risk of Visual Loss by 50%

Question 9

Early Treatment Diabetic Retinopathy (ETDRS) (1)

1. Eligibility: Diabetes types?
   a. What kind of DR did they look at?
2. Randomized patients into 3 groups: what were they?
3. Endpoints
   a. VA of what for AT LEAST 4 Months?

b. Doubling of what?
c. Progression of what?

Answer 9

1. Type 1 or Type 2 DM
   a. Mild NPDR thru Early PDR
2. a. EARLY vs. DEFERRED SCATTERED (Panretinal) Laser Photocoagulation (PRP) (They were wondering if PRP should be done before NEO forms, or after)
   b. FOCAL Laser Photocoagulation for MACULAR EDEMA vs. No Treatment
   c. 650 m Aspirin vs. Placebo (wanted to see if aspirin helped out)
3. a. VA

Question 10

Early Treatment Diabetic Retinopathy (ETDRS): RESULTS

1. 650 mg aspirin/day
   a. Did it alter progression of Retinopathy?

b. Did it prevent Cataracts?
c. Did it Increase risk of Vitreous Hemorrhage?
i. It was associated with DECREASED Risk of what?
d. BASICALLY, can they TAKE ASPIRIN?

2. Early Scatter Laser
   a. Reduction in Risk of Severe Loss?

b. Benefit of Early Tx MORE PRONOUNCED for PTs w/what?
c. So, what does that tell us?
3. Focal Laser for CSME
a. % DECREASED RISK of MODERATE VISUAL LOSS?
b. % Decreased risk of Severe Vision Loss (3 or more lines) if CSME is thru the Fovea?
c. Caused occasional moderate visual gain?
d. If there’s FOCAL Microaneurysms leakage on FA, what would they use?
e. If there was Diffuse Leakage on FA?
f. Re-evaluate when?
g. Is need for Additional Tx common?
h. What SHOULD BE TREATED BEFORE PRP use?
i. What can WORSEN CSME?

Answer 10

1. a. NO
   b. No
   c. No
   i. of CVD. Thus, no Ocular CI to Aspirin use when required for CVD or other indications
   d. YES. It’s okay to take Aspirin w/DR
2. a. SMALL (3.7% vs. 2.6%)
   b. w/Type 2 DM or Pt with Type I DM of LONG DURATION
   c. There really isn’t any benefit with the RISK of Laser Tx until later on (but small)
3. a. 50% (12-23%, Absolute Visual Gain)
   b. 80% (3 or more lines)
   c. Yes.
   d. Do FOCAL Photocoagulation
   e. Do Grid Photocoagulation!
   f. in 2-4 months.
   g. YES
   h. CSME!!
   i. CATARACT EXTRACTION!

Question 11

ETDRS: TAKE HOME LESSON

1. What Tx is INDICATED for CSME?
2. What about PDR?
   a. The idea is to TREAT before VISION does what?
3. If you have a PATIENT who has 20/15 and HAS CSME?
   a. What about PDR?

Answer 11

1. FOCAL (Focal Microaneurysms)/GRID (diffuse leakage) Photocoagulation Tx.
2. DO PRP!! REGARDLESS OF VA LEVEL!!!!
   a. Idea is to TREAT BEFORE VIsion gets WORSE!
3. REFER IT OUT!!!
   a. REFER IT OUT!! (any neo…get it OUT!)

Question 12

Clinical Trials

1. What are the 5 Trials?

Answer 12

1. DRS: Diabetic Retinopathy Study
2. ETDRS: Early Treatment Diabetic Retinopathy Study
3. Diabetic Vitrectomy Study (DRVS)
4. Diabetes Control and Complications Trial (DCCT)
5. United Kingdom Prospective Diabetes Study (UKPDS)

Question 13

Diabetic Retinopathy Study (DRS)

1. What were they evaluating?
2. Qualifications for the study?
3. This Study was looking at what Tx?
4. THIS STUDY DEFINED WHAT?

Answer 13

1. Vision loss from PDR
2. PDR in at LEAST ONE EYE or SEVERE NPDR in BOTH EYES
3. Scatter Photocoagulation vs. No Treatment (PRP vs. no PRP)
4. HIGH-RISK PDR!!!

Question 14

Diabetic Retinopathy Study (DRS)
RESULTS

1. This Study defined that PRP did what with Vision loss?
2. If he asks a question, which study defined that we should do PRP as a Treatment for PDR, what study would you choose?
3. Greatest Benefit for Patients with what kind of PDR?

Answer 14

1. that PRP reduced the RISK of Severe Vision Loss with PDR by >50%!
2. DRS!! (Diabetic Retinopathy Study)
3. with HIGH RISK PDR!

Question 15

The Diabetic VITRECTOMY Study (DRVS)

1. It defined that VITRECTOMY is INDICATED for what? (alot..)
   a. If you have Tractional RD, you’re going to get what?

Answer 15

1. TRACTION RD INVOLVING MACULA (was what he had highlighted)
   a. YOU’RE GOING to GET A VITRECTOMY!

Question 16

The Diabetic VITRECTOMY Study (DRVS) (2)

1. This Study ADVOCATES IMMEDIATE What?
   a. If you have what?
   b. If VA

Answer 16

1. VITRECTOMY
   a. Tractional RD (TRD)

b. 17%
c. To Wait 6 months to allow for spontaneous Clearing
d. When a unilateral one doesn’t go away in like 3 months.

2. a. BILATERAL HEMORRHAGE (fresh, in BOTH EYES, get it out IMMEDIATELY)
   b. Non-Clearing Hemorrhage
   c. Poor fellow Eye Acuity
   d. IDM shows advantage w/early Vitrectomy
   e. NIDDM Shows NO advantage to Early Vitrectomy!
   f. RD
   g. Macular Traction
   h. Active Retinopathy
3. 67% (THAT’s AWESOME!)…Do whatever Tx says when it gets to 50% benefit. (Risk vs. Benefit)
   a. of getting Vision that’s 20/40 or Better.

Question 17

Diabetes Control and Complications Trial (DCCT)

1. This TRIAL ONLY LOOKED at what TYPE of DIABETES?
   a. They had what kind of DR?
2. Primary Prevention:
3. Secondary Prevention
4. They were looking at what exactly?
5. ENDPOINT?
   a. So they were looking at what exactly?

Answer 17

1. TYPE 1!!!
   a. No RETINOPATHY or Mild-Moderate NPDR
2. DM 1-5 yrs; no DR
3. DM 1-15 Years; Mild-Mod DR
4. CONVENTIONAL vs. INTENSIVE BLOOD GLUCOSE CONTROL
5. Development/progression of Diabetic Retinopathy and Nephropathy
   a. Does Diabetic Retinopathy Get better or Worse (Yes, Length of TIME is the NUMBER 1 CAUSE for RISK FACTOR, but if you CONTROL IT, WILL IT SLOW DEVELOPMENT/PROGRESSION of DR is what they were looking at)

Question 18

Diabetes Control and Complications Trial (DCCT)

1. HbA1C: CONVENTIONAL?
2. HbA1C: INTENSIVE?
3. % of Conventional Tx Lost 3 or more lines of VA
4. % of Intensive Tx Pt lost 3 or more lines of VA
5. % that reduced mean risk Reduction for Development of Retinopathy with Intensive HbA1C Control
6. He Always puts in his chart 3 things.

Answer 18

1. 9.1
2. 7.2
3. 52%
4. 22%
5. 76%
6. TIGHT BP Control, TIGHT Blood Sugar Control, and TIGHT Cholesterol Control because this WORKS in preventing further progression and loss! (this study just looked at Blood glucose control and progression)

Question 19

Diabetes Control and Complications Trial (DCCT): Results: Secondary Intervention

1. INTENSIVE BLOOD GLUCOSE CONTROL
   a. % Reduction in 3-STEP Progression of DR
   b. % Reduction in PDR and SEVERE NPDR
   c. % Reduction in Photocoagulation
   d. % Reduction in Macular Edema

Answer 19

1. a. 54%
   b. 47%
   c. 56%
   d. 23%
   * better than getting PRP cuz you lose VF loss with burns.
   * Diabetes is like an unstoppable train…it just keeps going, BUT, you can Slow down the Train!

Question 20

United Kingdom Prospective Diabetes Study (UKPDS)

1. ELIGIBILITY for this STUDY?
   a. Size of study?
2. What did they do?
3. 2 Main Endpoints for this Study?
4. Conventional Tx: Main thing?
5. Intensive Tx

Answer 20

1. TYPE 2 DIABETES!!
   a. HUGE
2. Looked at Primary Prevention, Secondary Intervention, and Conventional vs. Intensive Blood Glucose Control
3. a. Development/Progression of DR
   b. Neuropathy/Nephropathy/Cardiovascular Outcomes
4. DIET, then gave them Sulphonylurea, Insulin, Metformin
5. Some given Sulphonylurea and others Insulin. OVERWEIGHT: Metformin

Question 21

United Kingdom Prospective Diabetes Study (UKPDS): SUMMARY

1. Intensive Blood Glucose Control
   a. % Reduction in MICROVASCULAR COMPLICATIONS?
   b. Comparing this to the DCCT study, which Type of Diabetes Responded better to Intensive Tx?

Answer 21

1. a. 25%
   b. TYPE 1 (but Type 2 data is still good though.)
   * there were decreases in reductions for need for Laser, 2-step progression of DR, need for cataract extraction, decreased Vit. heme and decreased legal blindness, but all of it was much less than type I study (DCCT: So Type 1 responded better)

Question 22

Glucose Control Studies Conclusions

1. IMPLEMENT what therapy AS EARLY AS POSSIBLE?
2. Maintain Intensive Therapy for how long?
3. Ask/Educate pts on what Diabetes number?
   a. SHOULD BE LESS THAN WHAT?
   b. Even a Small improvement did what?
   c. Encourage Control of what 2 things? ESP in what Type of DIABETES?

Answer 22

1. Implement INTENSIVE THERAPY as early as possible!
2. For as long as POSSIBLE!
3. HbA1C

a.

Question 23

Diabetic Macula Edema Clinical Trials

1. Intravitreal Steroid Injection Study (ISIS)
   a. First Randomized, Prospective, Single-blind, Dose-Escalation study of what?
   b. This STUDY was done to see if it was better than what?
   c. Number of Pts in this study compared to the previous ones?
2. Inclusion Criteria?

Answer 23

1. a. IVTA (Intravitreal Triamcinolone Acetonide)
   b. TO SEE if injections were better than PRP!
   c. ONLY 33 pts vs the thousands that were done in the previously discussed studies.
2. REFRACTORY DME, VA

Question 24

Intravitreal Steroid Injection Study (ISIS)-DME: Conclusions

1. Statistically significant improvement in Vision at what point? for what dose levels?
2. Dose response with what level of dosage was more effective?
3. EFFECT DIMINISHES BETWEEN what time?
4. % COMPLICATION RATE?
   a. Risks/Benefits

Answer 24

1. at 3 and 6 MONTHS for BOTH 2mg and 4mg DOSES
2. 4 mg more effective than 2 mg
3. BETWEEN 3 AND 6 MONTHS. Suggests NEED for Frequent RE-INJECTION
4. 30% (IOP, HEME, CATARACT, UVEITIS)
   a. 30% of the PEOPLE THEY INJECTED HAD ISSUES (THIS IS RIDICULOUS IN HIS MIND!)
   * So it created a lot more problems for peeps!

Question 25

Diabetic Retinopathy Clinical Research Network (DRCR) 1. Prospective Clinical Trial RANDOMIZING pts with DME to what? 2. Better trial than ISIS-DME? 3. THIS IS THE FIRST STUDY TO LOOK AT WHAT? a. So for the outcomes, it LOOKED at what?

Answer 25

1. Study: 3 groups: Standard Laser; 1 Injection of IVTA (triamcinolone Acetate) 1 mg, or IVTA 4 mg 1 injection 2. looked at 847 EYES (almost 700 subjects vs the 33 pts in the other study) 3. RETINAL THICKNESS (so it put Anatomical things into perspective) a. FUNCTION AND STRUCTURE for the outcomes!

Question 26

Diabetic Retinopathy Clinical Research Network (DRCR) (2008 this was done) 1. 4 MONTH OUTCOMES for IVTA? 2. 2 YEAR OUTCOME, which WAS BETTER? 3. SO STANDARD OF CARE is STILL WHAT?

Answer 26

1. It was BETTER than those who got the IVTA than Focal/Laser Grid. 2. BETTER to DO FOCAL/GRID PHOTOCOAGULATION 3. FOCAL GRID LASER as it was ORIGINALLY DEFINED BY ETDRS (PRP FOR MACULAR EDEMA!!!

Question 27

Diabetic Macular Edema 1. Achieve Systemic Control of what 3 THINGS?! 2. Characterize DME pattern with what 2 tests? 3. What Test TRACKS TREATMENT RESPONSE? 4. What should be done as an ADJUNCT to Laser?

Answer 27

1. Blood Sugar, Blood Pressure, and LIPIDS 2. FA and OCT 3. OCT! 4. Intravitreal Kenalog (Transient Response)

Question 28

New Frontiers 1. Sustained Drug Delivery Devices a. What Drug delivery DEVICES are CURRENTLY in TRIALS? b. Drug devices currently being used to treat what conditions? c. Advantages of Sustained drug delivery devices is what?

Answer 28

1. a. BIODEGRADABLE and NON-BIODEGRADABLE DRUG DELIVERY DEVICES b. DME, Uveitis (really popular for the sustained Uveitis that never really goes away), and other Inflammatory Conditions c. SUSTAINED CONCENTRATIONS for an Extended period of TIME

Question 29

Posurdex Dexamethasone Implant 1. Biodegradable? 2. Implantable? 3. What does it do? 4. how does it get into the eye? 5. Current Phase? a. Doing it on what patients? 6. What is the primary Purpose of FOCAL LASER? (is it to improve VA?) a. These injectables can actually do WHAT? 7. Results of study so far: a. 700 ug implant produced what to VA? b. It also did a REDUCTION in what? c. However, increased IOP in what % of eyes?

Answer 29

1. Yes 2. Yes 3. Releases intravitreally DEXAMETHASONE for 35 DAYS 4. Office-based w/32g Needle 5. Currently in PHASE II Study. (Phase II Dexamethasone Implant Study) a. CRVO, CME, Uveitis, and CSME 6. NO it DOESNT. Purpose is to PREVENT FURTHER LOSS of VA! a. Can actually IMPROVE VA! 7. a. Increase (increased 3 or more lines in about 20%) b. Significant reduction in Retinal Thickness (mean: 142 micron reduction) c. in 10% * Actually, study is currently in Phase 3

Question 30

Retisert Flucinolone Implant 1. Biodegradable? 2. Implantable? 3. Extended release for how long? 4. Procedure done where?

Answer 30

1. NO. Non-biodegradable 2. Yes 3. 3 YEARS 4. Surgical procedure done in OR!

Question 31

FAME STUDY: (2011): Fluocinolone Acetonide Intravitreal Implant for Macular Edema Study 1. Evaluating what? 2. Primary outcome 3. Secondary Outcome 4. Primary Outcome? 5. Visual Results significant? 6. AT 3 YEARS SOC and FA RESULTS were what?

Answer 31

1. efficacy and safety of implant. 2. measure >15 letter improvement in VA at 6 months. 3. to measure Reduction of Macula Thickness, and Leakage on FA 4. 6 and 9 months was better with FA group than SOC Group 5. NOT statistically significantly different b/w treatment arms at 1 YEAR (but had cataract formation) 6. NOT STATISTICALLY different b/w Tx Arms! * THIS Implant: 20,000 bucks. * Focal laser/Grid: few hundred bucks. *Less cheaper, less side effects