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)

• 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

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• Descriptive studies• Case reports• Reports of expert committees• Expert opinion• Meeting abstracts, unpublished proceedings

• 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

• 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)

• 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

• 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)

• 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

• 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)

• 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

• 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

• 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

• 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

• Alternative Approaches– RGP to SCL• Generally beneficial (Level II)

– Vision worse

– SCL to RGP• No studies

– Orthokeratology, Refractive Surgery• No studies

• Future– Neuromodulation

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

Thank you

QUESTIONS?