Here is the design of a clinical trial:

Official Title: SIGHT Study: Cost-effectiveness of InnFocus Microshunt (IMS) Implantation Versus Standard Trabeculectomy (TE)

Included conditions:
- Primary Open-angle Glaucoma

Study Armgroups:
- {'label': 'PRESERFLO Microshunt (formerly InnFocus Microshunt (IMS))', 'type': 'ACTIVE_COMPARATOR', 'description': 'The intervention group will undergo PRESERFLO (formerly InnFocus) Microshunt implantation (IMS).', 'interventionNames': ['Procedure: PRESERFLO Microshunt implantation']}
- {'label': 'Trabeculectomy', 'type': 'ACTIVE_COMPARATOR', 'description': 'The usual care/control group will undergo a standard trabeculectomy.', 'interventionNames': ['Procedure: Trabeculectomy']}

Interventions:
- {'type': 'PROCEDURE', 'name': 'PRESERFLO Microshunt implantation', 'description': 'The intervention consists of the microshunt implantation augmented with mitomycin C application.', 'armGroupLabels': ['PRESERFLO Microshunt (formerly InnFocus Microshunt (IMS))'], 'otherNames': ['InnFocus Microshunt implantation']}
- {'type': 'PROCEDURE', 'name': 'Trabeculectomy', 'description': 'The usual care / control group will undergo a standard fornix based trabeculectomy augmented with mitomycin C application.', 'armGroupLabels': ['Trabeculectomy']}

Primary Outcomes:
- {'measure': 'Intraocular pressure', 'description': 'The intraocular pressure is measured using a Goldmann applanation tonometer', 'timeFrame': '12 months postoperatively'}

Please estimate the sample size based on the assumption: 
Within-group standard deviation of 4.4, 90% power, one-sided significance level alpha of 0.025, and 20% loss-to-follow-up. For secondary outcomes, 90% power, two-sided alpha of 0.05, and within-group SD of 0.2.
Sample size
        The sample size is based on the primary outcome, IOP, a numerical response variable, to detect non-inferiority of an experimental group compared to a control group at 12âmonths of follow-up. A couple of studies have been published on the efficacy of the experimental group. Based on observed means of postoperative IOP from these studies [11, 26, 27], a mean IOP for the experimental group of 12âmmHg was chosen. The non-inferiority margin (control minus intervention) of ââ2.5âmmHg is chosen based on previous trials investigating glaucoma surgery [26, 28, 29]. Assuming this non-inferiority margin of ââ2.5âmmHg, a within-group standard deviation (SD) of 4.4, and an expected effect (control minus intervention) of 0.4 [5], 49 patients per group will be required to show non-inferiority with 90% power and a one-sided significance level alpha of 0.025. Accounting for 20% loss-to-follow up, we will need to include 62 patients per group, i.e., 124 patients in total.
        As for secondary outcome parameters, this number of patients should be sufficient to detect relevant differences in CDVA and postoperative intervention and complication rates. A 0.13 logMAR difference between the two groups (within group SDâ=â0.2) can be detected with 90% power and a two-sided alpha of 0.05. In the primary tube versus trabeculectomy study [5], the postoperative intervention and complication rate in the control group was 63 and 41%, respectively. With the planned sample size for our study (124 patients in total with 20% dropout), we can detect a difference of 32% (63% in the control group versus up to 31% in the intervention group) for postoperative interventions and 28% (41% in the control group versus 13% in the intervention group) for postoperative complications, with 90% power and a one-sided significance level alpha of 0.025.