report of the management & therapy subcommittee members: eric papas, chair (australia) joseph...
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Report of the Management & Therapy Subcommittee
Members:Eric Papas, Chair (Australia)Joseph Ciolino (US)Deborah Jacobs (US)William Miller (US)Heiko Pult (Germany), Afsun Sahin (Turkey)Sruthi Srinivasan (Canada)Joseph Tauber (US)James Wolffsohn (UK)J Daniel Nelson (US - Harmonization Subcommittee Member)
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• General Approach– Provide a clinical framework for treating an
individual complaining of CLD– Systematic Approach includes:
• History taking– Establishing the Current Status of the Lens and its
Relationship with the Eye and Adnexa plus Px requirements, needs and expectations
• Elimination of confounding issues– Identifying & Treating Non-Contact Lens Related, Co-existing,
Systemic and Ocular Diseases– Treating Evident Contact Lens Related Problems
• Treatment of the Symptomatic CL Patient with a Clinically Acceptable Lens
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Levels of Evidence – Clinical Studies •Level I
– Evidence obtained from at least one properly conducted, well-designed randomized controlled trial or evidence from studies applying rigorous statistical approaches
•Level II – Evidence obtained from one of the following:
• Well-designed controlled trial without randomization• Well-designed cohort or case-control analytic study from one
(preferably more) center(s)• Well-designed study accessible to more rigorous statistical analysis.
•Level III – Evidence obtained from one of the following:
• Descriptive studies• Case reports• Reports of expert committees• Expert opinion• Meeting abstracts, unpublished proceedings
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• Changing Material– Hydrogel to Silicone Hydrogel• No firm consensus
– Studies on both sides (pro and con)• Methodological problems in
many cases undermine value
• Balance of evidence mildly favourable– Need for more well designed
studies
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• Wetting Agents– Internal (Manufacturer Incorporated)• HA, PVA• No clear effect demonstrated (level II)
– External (Packaging solution additive or pre-conditioning treatment)• CMC, HPMC, Guar• Pre-conditioning may increase comfortable wearing
time (level II & III)• Incorporation into lens packing solution generally
gives short term benefits evident early in the wearing cycle (level II & III)
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• Lens Factors (Soft Lenses)– Edge shape (Level I-)
• Thin, knife edge > chisel > round– Base curve (Level I-,II,III)
• Steeper better (down to 8.3 mm)– Diameter (Level I-)
• Larger better (up to 13.5mm)– Back Surface Shape – Design (Level I-)
• No systematic pattern – Monocurve least preferred
– Centre thickness (Level II-)• Ineffective
– Practical Issues• Manipulation of individual parameters difficult due
to design component interdependence and unless lenses are custom made, control may lie with manufacturer
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• Lens Factors (Rigid Lenses)– Favourable• Larger diameters
– 10mm (Level II)• Rounded anterior edge shape (Level II)• Respecting the corneal contour
– Toric back surfaces for astigmatism (Level III)
– Unfavourable• Excessively steep fitting
– Optimal and slightly flat preferred (Level II)• Very thin lenses
– Flexure (Level I)
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• Changing the Care System– Clinical study evidence conflicting as to
benefits of change with a given material (Level I)
– Comfort benefits can accrue from optimising the combination of lens type and solution type (Level II)• Optimum combination may involve products
from different manufacturers– Evidence for any effect with RGPs is
scant
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• Tear Supplementation– Eye Drops, Wetting Agents
• Widely regarded as mainstay of treatment – Clinical benefit generally evident in trials
• 0.9% saline (Level II)• CMC, PVA (Level III)• 2% povidone (Level III)• Recent studies tend to favour more complex solutions
over saline alone
– Hydroxypropyl Cellulose Ophthalmic Inserts• Effective in reducing dryness symptoms after 1 m (Level
II & III)
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• Nutrition– Essential Fatty Acid (EFA) Supplementation• Beneficial in dry eye BUT…..• Little evidence in CL wearers
– No studies of omega-3 – Omega-6 (evening primrose oil) beneficial
• (Level I - female sample)
– Hydration• No studies
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• Punctal Occlusion– Balance of evidence suggests increased tear
volume is beneficial• Silicone plug superior to dissolvable collagen • Upper and lower occlusion better than lower lid
alone
– Other factors need consideration• Relative invasiveness• Specialist skills needed
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• Topical medication– Azythromycin
• Only one relevant study– 1% b.i.d. beneficial over 1 month (Level II)
– Cyclosporin• No clear evidence of benefit
– Two studies with contradictory results (Level I & II)
– Steriods• No studies
– Use not justified in view of potential risks
– NSAIDs• Soft CLs
– No studies• RGPs
– 0.1% diclofenac q.i.d may reduce post fitting adaptation (Level III)
– Anaeshtetics• Long term use insupportable
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• Environment– Few studies• Low humidity gives poorer RGP
comfort (Level III)• SCLs avoid dust, pollen, smoke, low
humidity (Level III)
• Blinking Behaviour– Can modify number of complete
blinks• No evidence for effect on CL comfort
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• Alternative Approaches– RGP to SCL• Generally beneficial (Level II)
– Vision worse
– SCL to RGP• No studies
– Orthokeratology, Refractive Surgery• No studies
• Future– Neuromodulation
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Bothersome symptoms or
comfortable wearing time shorter than
desired?
No further action required
Initiate management
Self reduction of wearing time
Is wearing time adequate for Px
needs?
Discontinuation/Dropout
Assess patient status
Eliminate co-existing disease
Fix sub-optimal contact lens
factors
Treatment of patient with
clinically acceptable
lens
Change Method of Correction
Bothersome symptoms or
comfortable wearing time shorter than
desired?
All strategies investigated?
Change care solution or care system
Eliminate care system/change to daily
disposable
Adjust replacement frequency
Change lens design and/or material
Tear Supplementation 1) Lubricant drops 2) Wetting drops 3) Lacrimal inserts 4) Punctal occlusion
Dietary Supplementation(Omega-6 Fatty Acid)
Topical Medication (Azithromycin)
Improve Environment
Bothersome symptoms or
comfortable wearing time shorter than
desired?
No
No
No
No
No
Yes
Yes
Yes
Yes
Yes
Yes
No
Summary of management strategies for contact lens related discomfort
– Determine most likely cause
– Identify corresponding treatment strategy
– Stepwise (additive) application of treatments to achieve maximum effect
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Thank you
QUESTIONS?