Momeni Moghaddam 2015.
Study characteristics | ||
Methods | Study design: RCT Number randomized: 60 (30 assigned to home‐based pencil push‐up therapy; 30 assigned to office‐based therapy) Unit of randomization: individual participant (convergence insufficiency is a binocular vision disorder) Number analyzed: assumed 60 (100%, no loss to follow up reported and no sample sizes provided in results tables) Number of centers: 1 Date of first enrolment: not reported Length of follow‐up: planned: 8 weeks; actual 8 weeks Sample size estimation: not reported |
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Participants | Country of recruitment: Iran Mean age: 21.4 ± 0.9 (SD) years in home‐based pencil push‐up therapy group; 21.2 ± 0.9 (SD) years in office‐based therapy group Sex: 60% were female in both groups Key inclusion criteria: Convergence Insufficiency Symptom Survey (CISS) score of ≥ 21 ; near exodeviation which was at least 4 Δ more than distance; remote NPC (≥ 6 cm); insufficient near PFV (not meeting Sheard's criterion, or break point < 15 Δ ); best corrected monocular VA of 20/25 or better at far and near. Key exclusion criteria: Constant strabismus; amblyopia; history of refractive surgery; vertical phoria of 1 prism diopter or more; presence of manifest or latent nystagmus; presence of eye disease; and/or a history of strabismus surgery. |
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Interventions |
Intervention regimen #1: home‐based pencil push‐up therapy (PPT) For home‐based PPT, the participants held a pencil at 50 cm along the midline. They were instructed to position themselves so that when they looked at the tip of the pencil, they were aware of diplopia at far. A target such a clock on the wall behind the pencil was used to control suppression with use of physiological diplopia. Next, the pencil was moved toward their eyes slowly, and the participants were instructed to try to maintain fixation so that the target appeared as a single pencil. When they perceived double vision of the target even with maximum effort, the pencil was moved back slowly until they regained fusion. If suppression occurred and one of the physiologic diplopic images disappeared, the participant was instructed to blink or shake the pencil as an anti‐suppression technique. The subjects performed this exercise at least three times a day for 5 minutes each time. Intervention regimen #2: office‐based vision therapy (OBVT) The office‐based therapy group was given exercises for improvement of vergence amplitude by prism, vergence facility, accommodative amplitude, and facility. These exercises were performed two days per week for 60 minutes. Participants had one minute break for each 5 minutes of therapy |
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Outcomes | Primary outcome: symptoms measured using Convergence Insufficiency Symptom Survey (CISS), near point of convergence, positive fusional vergence after 8 weeks of therapy Key secondary outcomes: primary and secondary outcomes were not distinguished No harms were reported |
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Notes | Founding sources: Zahedan University of Medical Sciences Subgroup analyses: none reported Trial registration: not available |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | "Block randomization was used to divide subjects into two groups: Home‐based PPT and office‐based therapy groups. Odd‐ numbered subjects were assigned to the home‐based therapy group and, even‐numbered subjects to the office‐based therapy group." |
Allocation concealment (selection bias) | Unclear risk | Not reported. |
Blinding (performance bias and detection bias) Primary outcome | Unclear risk | Not reported |
Blinding (performance bias and detection bias) Secondary outcomes | Unclear risk | Not reported. |
Incomplete outcome data (attrition bias) Primary outcome | Low risk | All participants completed follow up. |
Incomplete outcome data (attrition bias) Secondary outcomes | Low risk | See above. |
Selective reporting (reporting bias) | Unclear risk | No prior trial registration with which to compare. |