Here is the design of a clinical trial:

Official Title: Quality-Assured Follow-up of Quiescent Neovascular Age -Related maculaR dEgeneration by Non-medical Practitioners: a Randomised Controlled Trial

Included conditions:
- AMD

Study Armgroups:
- {'label': 'Control Arm', 'type': 'OTHER', 'description': 'All investigations are the same in both arms, but patients within this arm will be seen in the hospital as per standard practice.', 'interventionNames': ['Diagnostic Test: OCT', 'Diagnostic Test: Visual Acuity']}
- {'label': 'Study Arm', 'type': 'OTHER', 'description': 'All investigations are the same in both arms, but patients within this arm will be seen in a community optometrist practice.', 'interventionNames': ['Diagnostic Test: OCT', 'Diagnostic Test: Visual Acuity']}

Interventions:
- {'type': 'DIAGNOSTIC_TEST', 'name': 'OCT', 'description': 'Optical Coherence Tomography of study eye.', 'armGroupLabels': ['Control Arm', 'Study Arm']}
- {'type': 'DIAGNOSTIC_TEST', 'name': 'Visual Acuity', 'description': 'Visual acuity measured by ETDRS', 'armGroupLabels': ['Control Arm', 'Study Arm']}

Primary Outcomes:
- {'measure': 'The proportion of Participants who reactivate within 12 months of randomisation but are not identified as having re-activated (false negatives).', 'description': 'The proportion of Participants who reactivate within 12 months of randomisation but are not identified as having re-activated (false negatives).', 'timeFrame': '12 months'}
- {'measure': 'Primary economic outcome: Incremental cost per quality adjusted life year (QALY) gained over the estimated patient lifetime estimated from an economic model informed by trial data.', 'description': 'Primary economic outcome: Incremental cost per quality adjusted life year (QALY) gained over the estimated patient lifetime estimated from an economic model informed by trial data.', 'timeFrame': '12 months'}

Please estimate the sample size based on the assumption: 
The test of non-inferiority will be one-sided at the 2.5% significance level with 90% power. A conservative estimate of 10% loss to follow-up is assumed.
Sample size calculation
        The ECHOES study has shown that the rate of false negatives per lesion assessment when conducted by an ophthalmologist was 62/994, that is, 6.2% (95% CI of 4.8% to 7.9%).6 Over the course of 1âyear, a patient will typically have lesions assessed on 12 occasions. The overall chance of being a false negative at any point during the 12 months of follow-up is estimated at 20% (determined by the summation of the probability of reactivating and the probability of being a false negative and deducting the chance of being a false negative on repeat occasions, with figures estimated from Madhusudhana et al).
8 This estimate requires adjustment for the fact that ECHOES figures were based on scenarios and vignettes and did not factor in additional patient information that may be available to the clinician, thus the false negative rate is expected to be lower than 20% in reality. The test of non-inferiority will be one sided at the 2.5% level. This approach is the conservative approach which is the standard for regulatory approval of new pharmaceuticals and many devices.9 While approval has been made on the basis of a non-inferiority design with a one-sided alpha of 5%, this is generally frowned on and thus we have adopted the more conservative approach. One of the major challenges in the design of a non-inferiority trial is the determination of the non-inferiority margin. This margin is the smallest difference between patient management approaches which, if true, would mean that management by non-medical professionals is declared inferior. We adopted a non-inferiority margin of 10%, the same as margin adopted by the ECHOES study and appraised by five peer reviewers, none of whom suggested it was too large. It has subsequently been published within the BMJ Open paper6 and attracted no criticism or referee comment about it being too high.
        With an overall sample size in each group of 337, a two-group large-sample normal approximation test of proportions with a one-sided 0.025 significance level will have 90% power to reject the null hypothesis that the test and the standard are not equivalent (the difference in proportions, Ïâ â Ïâ, is 0.1 or farther from zero in the same direction) in favour of the alternative hypothesis that the proportions in the two groups are equivalent, assuming that the expected difference in proportions is 0 and the proportion in the standard group is 0.2.
        Thus, data of the primary outcome would be required from 674 participants in total. Seven per cent loss to follow-up was observed in the first year of the IVAN study10 on a patient population with nAMD. We adopted a more conservative estimate of 10% loss to follow-up, leading to an overall sample size of 742 participants. Of these, 72 participants are expected to be recruited in the pilot trial, with the remainder recruited from the full trial. Sample size calculation was conducted using nQuery Advanced software V.8.1.2.0.