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RANDOMIZED CLINICAL TRIALS IN GLAUCOMA- WHAT DO THEY TELL US?. Dr Jyoti Shetty B.W.Lions superspeciality eye hospital. Randomized clinical trials. First major scientific evidence that treatment for glaucoma decreased visual loss Multicentric, prospective studies How do they help us?.

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Randomized clinical trials in glaucoma what do they tell us

RANDOMIZED CLINICAL TRIALS IN GLAUCOMA- WHAT DO THEY TELL US?

Dr Jyoti Shetty

B.W.Lions superspeciality eye hospital


Randomized clinical trials
Randomized clinical trials US?

  • First major scientific evidence that treatment for glaucoma decreased visual loss

  • Multicentric, prospective studies

  • How do they help us?


Nei clinical trials
NEI clinical trials US?

CNTGS CIGTS

AGIS

OHTS EMGT

  • Layouts, results, relevance to clinical decision making


Ocular hypertensive treatment study ohts
Ocular Hypertensive Treatment Study (OHTS) US?

  • Purpose

    - Conversion rate to POAG in

    treated vs untreated groups.

    - Risk factors for progression to

    POAG


OHTS US?

Randomized

n= 1636

Observation Medication

n=819 n=817

  • Treatment goal –dec IOP by 20%

  • Prim outcome – dev of POAG ( VF, ONH)


OHTS US?

  • Summary of results

    - At 5 yrs dev of POAG

    * 4.4% in treated eyes

    * 9% in untreated eyes

    * 50% of risk

    * diff with time

    - Race not predictive (multivariate

    analysis)


OHTS US?

  • Summary of results

    - Conversion 6.4% in treated eyes

    4.3 % in untreated eyes

    - Incidence of POAG higher

    - Risk factors identified for onset of POAG

    * Age

    * Vert CD

    * PSD

    * IOP

    * CCT


OHTS US?

  • Summary of results

    CCT < 555 & IOP > 25 CCT < 555 & CD > 0.5

    Risk 36% Risk 22%

    CCT > 588 &IOP > 25 CCT > 588 & CD >0.5%

    Risk 6% Risk 8%


Clinical useful points from ohts
Clinical useful points from OHTS US?

  • OHT – What to do

    * Treat all

    * Treat no one

    * Treat some

    -- Is treatment effective

    DOES OHTS HAVE ANSWERS FOR THIS


Clinical useful points from ohts1
Clinical useful points from OHTS US?

  • Absolute risk reduction = 9.5% - 4.5%= 5.1%

  • NNT = 1 / 5.1 = 20 ( To prevent 1 conversion to POAG)

  • 90% of OHT did not convert in 5 yrs

  • Conversion to early POAG

    - No effect on QOV

    - Not a sentence to eventual

    blindness

  • So can afford to wait for evidence of progression


Clinical useful points from ohts2
Clinical useful points from OHTS US?

  • Treat only patients at high risk.

  • Risk factors – risk calculator

    www.discoveriesinsight.org

  • Importance of CCT

  • ONH & VF monitoring at every FU

  • SWAP,GDx OCT – application not studied in OHTS

  • Study – Rx effective , of the 9.6% that converted half could be prevented by Rx

  • OHTS - ? Conversion after longer FU

If not high risk waiting to treat OHT till conversion- better strategy ( vision related QOL)


Collaborative initial glaucoma treatment study cigts
Collaborative initial glaucoma treatment study (CIGTS) US?

  • Objective

    • Is medical or surgical therapy better as an initial treatment of POAG taking into consideration IOP control, VF progression & QOL.

607 PATIENTS

MEDICAL

SURGICAL(TRAB)

FIRST TIME A TARGET IOP ALGORITHM USED


Cigts
CIGTS US?

  • RESULTS

    • At 5 yrs both effective

    • Control of IOP lower by surgery (48%), medical (35%)

    • VF loss greater in surgery (cataract)

    • QOL initially better with medical group


Clinical useful points from cigts
Clinical useful points from CIGTS US?

  • Early POAG – medical Rx effective

  • Our scenario – compliance/cost – deciding factor for either modality

  • Concept of target IOP – must in our management.

  • Drawback – study duration too short for Rx recommendation.


Early manifest glaucoma treatment study emgts
Early manifest glaucoma treatment study (EMGTS) US?

  • Only glaucoma study where diagnosed early POAG not treated

  • Evaluated effectiveness of IOP reduction in early POAG

255 pts

129 - medical

126 - control

Rx ALT & Betaxolol only


Emgts results
EMGTS – results US?

  • Progression

    • 62% - control

    • 45% - treated group

  • 25% IOP - risk of progression by 50%

  • Risk of progression less with larger initial IOP drop

  • Risk of progression by 10% / mm Hg IOP from baseline


Clinical useful points from emgts
Clinical useful points from EMGTS US?

  • 25% IOP - progression from 62 – 45%

  • Regular FU every 3 – 6 months with ONH & VF must – not commonly practiced.

  • Pts with low risk of progression left untreated – no effect on QOL till lifetime

  • Drawbacks – Rx options limited – better drugs now


Advanced glaucoma intervention study agis
Advanced glaucoma intervention study (AGIS) US?

  • Objective – to determine if ALT or surgery is preferred Rx for advanced glaucoma on max tolerated medical Rx.

781 eyes

ALT

TRAB

TRAB

(ATT)

TRAB

ALT

TRAB

(TAT)


Agis results
AGIS - Results US?

  • Relationship of IOP & VF progression.

    • Predictive analysis – IOP < 14 mm Hg did better

    • Associative analysis – low IOP & low IOP fluctuation - Decreased progression


Results agis

TAT US?

IOP

Better for whites

ATT

failure

Better for blacks

Results - AGIS

Risk of cataract after TRAB after 5 years – 78 %


Clinical useful points from agis
Clinical useful points from AGIS US?

  • Advanced glaucoma IOP < 14 - VF prog.

  • So lower target IOP aimed for

  • Not only lower IOP but lower fluctuation of IOP

  • Incidence of cataract after glaucoma surgery - high


Collaborative normal tension glaucoma study cntg
Collaborative normal tension glaucoma study (CNTG) US?

  • Objective:

    • To determine if aggressive IOP lowering effective in CNTG.

  • Goal – 30% from baseline IOP


Cntg results
CNTG – results US?

  • Prog in 12% of Rxed eyes & 35% in untreated group.

  • 30% reduction possible even by medicines.

  • Treated pts that progressed

    • Non IOP related

    • target IOP wrong


Clinical useful points from cntg
Clinical useful points from CNTG US?

  • IOP lowering beneficial even in NTG

  • IOP should be lowered >30% - low target IOP should be aimed for.

  • Newer medications available now (PG analogues, combination therapy) – easier


Take home message from clinical trials
Take home message from clinical trials US?

  • Efficient patient care – practice of evidence based Rx

  • IOP - + risk factor for all glaucomas

  • Recognize threat – lower IOP – lower risk of progression

  • Set a target IOP after asessing risk factors for progression

    • 20%, - OHT

    • 30% - moderate loss,

    • 40% - sever loss

    • If documented risk of progresion - further 15%


Take home message from clinical trials1
Take home message from clinical trials US?

  • Choice of medical therapy first – change only if target IOP not achieved.

  • Remember QOL – balance efficacy with safety, side effects, economic stress, compliance.

  • Newer PG analogues & combination therapy available – better compliance, flatter diurnal curve.


Take home message from clinical trials2
Take home message from clinical trials US?

  • Surgical therapy – safe

  • Rx OHT only if high risk (risk calculator)

  • CCT measurements at present unavoidable for correct mgt of glaucoma esp. OHT.

  • All forms of Rx - incidence of cataract

  • Disiease progression with time

  • Newer diagnostics – SWAP/FDT/GDx/OCT –quantification of progression better


Take home message from clinical trials3
Take home message from clinical trials US?

  • Progression of glaucoma does not necessarily mean threat to QOL.

  • Aim of Rx not no progression at all but reduction to such a level that QOV not endangered during patients lifetime


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