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. 2019 Mar 28;2019(3):CD012743. doi: 10.1002/14651858.CD012743.pub2

NCT03106181.

Trial name or title A comparison of cataract surgery alone and cataract surgery with iStent
Methods Study design: parallel‐group RCT
Unit of randomization: unclear
Number randomized: not reported
Unit of analysis: not reported
Number analyzed: not reported
Exclusions and losses to follow‐up: not reported
Handling of missing data: not reported
Participants Country: Australia
Age: not reported
Gender: not reported
Inclusion criteria:
  1. age > 18 years

  2. diagnosis of mild‐to‐moderate OAG

  3. presence of cataract requiring surgery

  4. good understanding of both verbal and written English

  5. able to provide informed consent


Exclusion criteria:
  1. recent intraocular surgery within last 3 months

  2. other ocular pathology affecting visionInability to complete the elements of the study, e.g. coma, hemodynamic instability, ventilator dependence, that could be of concern in the investigator's judgment

  3. non‐elective hospitalization within the past 60 days that could be of concern in the investigator's judgment

  4. medical illness that in the judgment of the investigator would jeopardize the safe completion of the study. Examples include cancer, chronic inflammatory disease, chronic liver insufficiency, epilepsy, thrombocytosis


Diagnoses in participants: OAG
Interventions Intervention 1: iStent inject
Intervention 2: phacoemulsification
Length of follow‐up: 2 years
Outcomes Primary outcomes: IOP reduction up to 2 years
Secondary outcomes: number of glaucoma medications; participant treatment satisfaction up to 2 years
Safety outcomes: not reported
Starting date 10 April 2017
Contact information Jennifer C Fan Gaskin, FRANZCO
drjfan@gmail.com
Notes Type of study: awaiting classification, described as "recruiting" on ClinicalTrials.gov
Funding source: Glaukos Corporation, Laguna Hills, CA, USA provided funding/support
Disclosures of interest: not reported
Publication language: not reported
Trial registration: NCT03106181