Skip to main content
. 2019 Mar 28;2019(3):CD012743. doi: 10.1002/14651858.CD012743.pub2

Vold 2016.

Methods Study design: parallel‐group RCT
Unit of randomization: participant (1 eye per participant)
Number randomized: 101 participants; 54 eyes of 54 participants in the 2 iStents without combined phacoemulsification and 47 eyes of 47 participants in medical therapy group
Unit of analysis: participant (1 eye per participant)
Number analyzed: 73 participants; 39 eyes of 94 participants in the 2 iStents without combined phacoemulsification and 34 eyes of 34 participants in medical therapy group
Exclusions and losses to follow‐up: unclear; data not available for 28 participants at 36 months
Handling of missing data: available case
Participants Country: Yerevan, Armenia (single site)
Age (mean ± SD): 64.5 ± 11.1 years in the 2 iStents without combined phacoemulsification group; 62.0 ± 11.1 years in the medical therapy group
Gender: 37 men and 57 women in the 2 iStents without combined phacoemulsification group; 48 men and 50 women in the medical therapy
Medicated IOP (mean ± SD): not applicable; enrolled only treatment‐naïve participants
Inclusion criteria:

  1. people with phakia with newly diagnosed primary OAG, PEX, or OHT

  2. have not undergone prior treatment of any type

  3. IOP ≥ 21 mmHg and ≤ 40 mmHg

  4. C:D ratio ≤ 0.9

  5. normal angle anatomy


Exclusion criteria:

  1. uveitic, neovascular, or angle‐closure glaucoma

  2. glaucoma associated with vascular disorders

  3. corneal pathology or prior corneal surgery

  4. congenital or traumatic cataract or prior cataract surgery

  5. retinal or optic nerve disorders

  6. any ocular disease or condition that "in the opinion of the investigator, would place the subject at significant risk, confound study results, or interfere with study participation"

  7. fellow eye in clinical trials

  8. pregnant or nursing women


Diagnoses in participants: POAG, PEXG, or PG
Interventions Intervention 1: 2 iStents without combined phacoemulsification
Intervention 2: medical therapy, consisting of topical travoprost (Travatan 0.004%; Alcon, Fort Worth, TX, USA)
Length of follow‐up: 3 years
Outcomes Primary outcomes: mean IOP regardless of additional medical therapy; mean IOP in eyes that had not received additional therapy after initial treatment at 12, 24, and 36 months
Secondary outcomes: proportion of eyes with postoperative IOP ≤ 18 mmHg without additional medical therapy; proportion of eyes with postoperative IOP ≤ 15 mmHg without additional medical therapy; number of participants for whom medication had been added; at 12, 24, and 36 months
Safety outcomes: adverse events and complications; mean deviation in visual field; mean C:D ratio; mean central corneal thickness; proportion of participants with BCVA 20/40 or better, 20/100, and 20/100 separately; at 12, 24, and 36 months; proportion of participants with progression of cataract and proportion of participants with need for cataract surgery at 36 months
Notes Type of study: published
Funding source: Glaukos Corporation, Laguna Hills, CA, USA provided funding/support
Disclosures of interest: investigators reported receiving non‐financial, financial, and non‐study financial support from Glaukos
Publication language: English
Trial registration: NCT01443988
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Random sequence generation method not reported.
Allocation concealment (selection bias) Unclear risk Allocation concealment not reported.
Blinding of outcome assessment (detection bias) 
 Number of IOP‐lowering drops High risk Investigators described the study as employing an "open‐label unmasked strategy" and "neither subjects nor clinicians were masked to treatment."
Blinding of outcome assessment (detection bias) 
 IOP measurement High risk Investigators described the study as employing an "open‐label unmasked strategy" and "neither subjects nor clinicians were masked to treatment."
Incomplete outcome data (attrition bias) 
 All outcomes High risk Available case analysis of 73/101 (72%) participants at 36 months.
Selective reporting (reporting bias) Unclear risk Some differences between trial registration and trial report: outcomes modified screening in mean diurnal IOP (mmHg) at the month 12 visit to mean IOP reduction at 3 years; diurnal measurements of IOP were not performed.

BCVA: best‐corrected visual acuity; C:D: cup‐to‐disk; IOP: intraocular pressure; OAG: open‐angle glaucoma; OHT: ocular hypertension; PEXG: pseudoexfoliative glaucoma; PG: pigmentary glaucoma; POAG: primary open‐angle glaucoma; RCT: randomized controlled trial; SD: standard deviation.