Background and Importance Dry eye disease is a frequent cause of ophthalmology consultation (5%–34% of population worldwide). Severe forms, refractory to conventional treatments (artificial tears, topical corticosteroids, cyclosporine A, contact lenses, punctual occlusion, systemic diseases appropriate management), are responsible for a significant visual impairment and disability. Autologous serum eye drops (ASEDs) are then proven to be an interesting therapeutic alternative. First, in March 2019 we carried out a national inventory of ASED preparations practice that highlights: low supply (13 producer centres) and production heterogeneity.
General objective to improve ASEDs quality, safety and supply in our country care institutions.
Specific objectives to define the consensual items, in order to establish a national standardised preparation protocol.
Method for consensus reaching Delphi method. Four protocol parts aborded: sampling, preparation, controls, conservation. Expert panel recruited by remobilising centres approached in 2019 (ASEDs producers, non-producers, or did not respond). Local steering group: pharmacy resident, head of compounding unit, pharmacy methodologist. Circuit: questionnaire construction, mailing with link access to Google Forms®, response analyses, consensus rate calculation (consensus when ≥ 80%), result synthesis, anonymous referral to experts. As many rounds as necessary to achieve consensus.
Twelve answering experts After 4 rounds: out of 39 proposals initially submitted, 26 validated and 10, abandoned. In sampling: 15 items validated, 5 dropped. Preparation: 5 validated, 1 dropped. Control: 3 validated, 4 dropped. Conservation: 3 validated. Four rounds took 86 days.
Conclusion and Relevance A standardised protocol ASEDs preparation will be proposed. This could improve the supply of care across the country. Method strengths: Expert opinion solicited on the initial questionnaire; qualified experts on the topic; no geographical limitations; anonymity avoiding opinion leader influence; applicability criteria. Limitations: no ophthalmologists, biologists, patients in the panel; no participation of the largest eye drop producer (despite requests).
A clear definition of this eye drop status (pharmaceutical preparation or not) is also necessary.
Biochemical quality controls, abandoned, to be resubmitted (molecules supposed to support ASEDs efficacy). Supplementary round necessary to decide the fate of the last item (solution volume in each eye drop bottle).
References and/or Acknowledgements 1. Acknowledgements to all colleagues participating to 2019 study or/and Delphi method.
Conflict of Interest No conflict of interest
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