Pandita 2007.
| Methods |
Study design: RCT Study grouping: parallel group, with one eye per participant randomised to one of the interventions Exclusions after randomisation: not reported Losses to follow‐up: 109 patients, from 120 randomised, completed the three‐month follow‐up. Of 120 participants (eyes), three were transferred to a distant destination, one developed cystoid macular edema, one became seriously ill, one died, two returned at the five‐month follow‐up, and three refused to return. How missing data were handled: not reported Reported power size calculation? no |
|
| Participants |
Baseline characteristics Non‐blue‐light filtering IOL group
Blue‐light filtering IOL group 1 (SN60AT)
Blue‐light filtering IOL group 2 (SN60WF)
Inclusion criteria: people aged 50‐70 years and scheduled for phacoemulsification for uncomplicated senile cataracts with in‐the‐bag implantation of an AcrySof IOL. Exclusion criteria: complicated cataract, coexisting ocular pathology, glaucoma, axial length greater than 25.0 mm, nondilating pupils, history of intraocular surgery, laser therapy, retinopathy, optic nerve or macular diseases, refusal or unable to maintain follow‐up, diabetes with or without retinopathy, preoperative and postoperative astigmatism greater than 1.5 diopters (D), residual posterior capsule plaque, postoperative best corrected visual acuity (BCVA) 20/25, and posterior capsule opacification. Eyes with intraoperative complications such as posterior capsule tear, zonular dialysis, or uveal manipulation. Comparison of study groups at baseline: there was no statistically significant difference in visual acuity, age, and sex ratio between the three groups. Only 109 of the 120 randomised participants are included in the analysis and reported in baseline characteristics. |
|
| Interventions |
Intervention characteristics Non‐blue‐light filtering IOL
Blue‐light filtering IOL 1
Blue‐light filtering IOL 2
|
|
| Outcomes | The main outcome measure was the difference in contrast sensitivity between IOLs at each spatial frequency. Contrast sensitivity, measured using the CSV‐1000E contrast sensitivity chart test face (Vector Vision) at three, six, 12, and 18 cycles per degrees (cpd) under photopic conditions (85 cd/m2) and mesopic conditions (2.7 cd/m2) with 4.0 mm and 6.0 mm fixed central apertures, with and without glare, at three months postoperatively. The outcome measure was distance BCVA, measured at three months postoperatively. |
|
| Identification |
Sponsorship source: Funding sources: not reported Declaration of interest: no author has a financial or proprietary interest in any material or method mentioned Country: India Setting: ladevi Cataract IOL Research Centre, Ahmedabad, India Comments: Date study conducted: December 2005‐February 2006 Trial registration number: not reported Contacting study investigators: trials authors contacted on 14 August 2017 regarding contrast sensitivity unit of error (specifically, whether it was the SD or a different unit or error); no response was received to this email. As a result, we could not incorporate these data in a meta‐analysis. Corresponding author's name: Dr Abhay R Vasavada Institution: Iladevi Cataract Research Centre, Raghudeep Eye Clinic Email: icirc@abhayvasavada.com Corresponding author's address: Abhay R. Vasavada Iladevi Cataract IOL Research Centre Raghudeep Eye Clinic, Gurukul Road, Memnagar, Ahmedabad–380 052, India |
|
| Notes | None | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Quote: "Computer‐generated random numbers" Judgement comment: computer generated list used to assign interventions |
| Allocation concealment (selection bias) | Unclear risk | Judgement comment: not reported how allocation administered. Study is described as “randomised” but with no further details |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk | Quote: "triple‐masked trial (neither participant nor investigator responsible for patients was aware of IOL type)" Judgement comment: clearly stated that participants and personnel not aware of which treatment received |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Judgement comment: clearly stated that outcome assessors were masked |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Quote: "The drop‐out was 11 of 120 patients (9.2%)." Judgement comment: missing data less than 20% (i.e., more than 80% follow‐up) and equal follow‐up in both groups and no obvious reason why loss to follow‐up should be related to outcome. |
| Selective reporting (reporting bias) | Unclear risk | Judgement comment: no access to protocol or trials registry entry |
| Other bias | Low risk | Judgement comment: no other apparent sources of bias |