The CeeOn 911 silicone IOL, with sharp rectangular optic edges, showed an effect on preventing PCO that was similar to that of the AcrySof IOL. When a discontinuous capsular bend is created by an IOL with sharp optic edges, the bend may induce contact inhibition of migrating LECs regardless of the lens' material composition.

There are several ocular conditions for which there is an unmet medical need. In some of these conditions, surrogate endpoints as well as new clinical endpoints are needed to help speed up patient access to new medicines. Interaction with European regulators through the pathway specific for the development of biomarkers or novel methods is encouraged.

T he objective of this subcommittee was to summarize the evidence in clinical trials on meibomian gland dysfunction (MGD) and to use this information to make recommendations for best-practice clinical trial design for this condition.We conducted a PubMed and Medline literature review (through the end of 2009) to identify treatment or observational trials. Our search terms were those commonly used interchangeably with MGD, including (in addition to MGD) posterior blepharitis, meibomian gland disease, and tarsal gland disease. The level of evidence for each study was classified (Table 1) according to American Academy of Ophthalmology (AAO) Classification Scheme. In short, level I evidence includes evidence obtained from at least one properly conducted, well-designed randomized controlled trial. It could include meta-analyses of randomized controlled trials. Level II includes evidence obtained from welldesigned controlled trials without randomization, well-designed cohort or case-control analytic studies, preferably from more than one clinical center or from multiple-time series with or without the intervention. Level III includes evidence obtained from descriptive studies, case reports, or reports of expert committees/organizations (e.g., panel consensus with external peer review). Additional information on levels of evidence is found in Table 1 of The Report on Management and Therapy. In some cases, the trial designs were not sufficiently described to have more than a tentative grading. Further, recent publications (August 2009 and later) were purposely excluded from Table 1.Articles were reviewed according to the key components that are necessary for protocol design in determining safety and efficacy of a new treatment: objectives, trial design and methodology, patient group, inclusion criteria, exclusion criteria, outcome measures, treatment, and statistical considerations. We also evaluated clinical trials that had been registered at ClinicalTrials.gov if they included a summary of key trial design features. Further, a summary of key design features of the registered trials plus recommendations for future trials are suggested.The review and summary were also based on the committee's personal expertise, including experience in clinical trials in ocular disease and in MGD. The initial search was performed in March 2009 and updated in July 2009. Twenty-six eligible papers 1-26 were identified and reviewed.During the review, committee members found that the study investigators in the published papers often had not been explicit in describing their methods. As a result, the members, who conducted their reviews independently of one another, often interpreted the available data differently. The various interpretations are included in this summary.Few publications qualify as well-designed randomized controlled trials. Aside from the three studies graded level I, there are additional trials that were randomized and controlled. Some were open-label with very small sample sizes and seemed to be lacking information on the ...

ObjectiveThe Growth Hormone Research Society (GRS) convened a Workshop in 2017 to evaluate clinical endpoints, surrogate endpoints and biomarkers during GH treatment of children and adults and in patients with acromegaly.ParticipantsGRS invited 34 international experts including clinicians, basic scientists, a regulatory scientist and physicians from the pharmaceutical industry.EvidenceCurrent literature was reviewed and expert opinion was utilized to establish the state of the art and identify current gaps and unmet needs.Consensus processFollowing plenary presentations, breakout groups discussed questions framed by the planning committee. The attendees re-convened after each breakout session to share the group reports. A writing team compiled the breakout session reports into a document that was subsequently discussed and revised by participants. This was edited further and circulated for final review after the meeting. Participants from pharmaceutical companies were not part of the writing process.ConclusionsThe clinical endpoint in paediatric GH treatment is adult height with height velocity as a surrogate endpoint. Increased life expectancy is the ideal but unfeasible clinical endpoint of GH treatment in adult GH-deficient patients (GHDA) and in patients with acromegaly. The pragmatic clinical endpoints in GHDA include normalization of body composition and quality of life, whereas symptom relief and reversal of comorbidities are used in acromegaly. Serum IGF-I is widely used as a biomarker, even though it correlates weakly with clinical endpoints in GH treatment, whereas in acromegaly, normalization of IGF-I may be related to improvement in mortality. There is an unmet need for novel biomarkers that capture the pleiotropic actions of GH in relation to GH treatment and in patients with acromegaly.

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