[Summary text]
Patients with age-related cataract with astigmatisme prior to cataract surgery
Cataract surgery with implantation of toric IOLs versus non-toric IOLs of comparable optical desing
(spheric/aspheric)
Spectacle indepence (surrogate measure: uncorrected distance visual acuity ≥ 0.8)
Comparison of spectacle indepence in patients implanted with toric IOL versus non-toric IOL
comparison of spectracle indepence in patients implanted with toric IOL versus non-toric IOL but with limbal
relaxing incisions????
RCT
Compares UCDVA, spectacle independence and safety in patients receiving toric
(AcrySof Toric) or non-toric (Acrysof) IOL
Country and clinic: multicenter study in USA
Patients with age-related cataract and preexisting corneal astigmastism
Demographics of study population: 55.1% female, mean age was 71 years
Follow-up: 1 year postoperatively
Group 1: toric IOL (Acrysof Toric)
Group 2: spherical IOL (Acrysof SA60AT)
UCDVA at 1 year postoperatively was 20/25 or better in 154/243 in Group 1 and
98/237 in Group 2
Distance vision spectacle independence at 6 months postoperatively was
147/241 in Group 1 and 86/236 in Group 2
Safety: complications (e.g. macular edema, retinal detachment, additional
surgical procedures) occured in 11/243 in Group 1 and 3/237 in Group 2
The study was sponsored by Alcon Laboratories Inc. Data from the study were
considered during the approval process of the AcrySof Toric IOL by the United
States Food and Drug Administration
Study design: Randomized controlled trial
Study grouping: Parallel group
Baseline Characteristics
Intervention
Kontrol
Overall
Included criteria: 21 years or older, bilateral age-related cataract, and bilateral regular corneal astigmatism of at leas 1.25D.
Excluded criteria: Irregular corneal astigmatism, Fuchs endothelial dystrophy stage 2 or higher, glaucoma related extensive visual field loss, or and expected postoperative corrected distance visual acuity of less than 20/40
Pretreatment: Age, mean (range) intervention: 74 (50-88), male %: 49%Age, mean (range), kontrol: 74 (49-87), male %: 54%
Intervention Characteristics
Intervention
Kontrol
Brilleafhængighed
Antal patienter der ikke opnåede postop UCDVA 0.8 (snellen) eller bedre
Antal komplikationer
Jesper Hjortdal on 28/04/2019 20:55
Select
A: RCT. Inkluderes.
Observational study describing the outcome after bilateral implantation with toric
IOLs but did not compare to a group not receiving toric IOL implantation
Prospective observational study describing the rotational stability of Rayner
T-flex. Does not compare visual function to patients not receiving toric IOL
Retrospective study comparing the outcome after implantation of two different
types of IOLs (AcrySof Toric and AT-Torbi) but does not compare to patients not
receiving toric IOL implantation
Prospective, observational study describing the outcome after implantation of a
toric IOL (Acri.Comfort 646 TLC) but does not compare to patients not receiving
toric IOL implantation
Prospective case series describing the outcome after implantation of a toric IOL
(AcrySof) but does not compare to a group not receiving toric IOL implantation
Prospective case series describing the outcome after implantation of a toric IOL
(AT Lisa 909M) but does not compare to a group not receiving toric IOL
implantation
Wrong study design
Wrong study design
Prospective, observational studies describing the outcome after implantation of a
toric IOL (AcrySof) but does not compare to a group not receiving toric IOL
implantation
Observational study describing the outcome after implantation of a toric IOL
(AcrySof) but does not compare to a group not receiving toric IOL implantation
RCT comparing the outcome after implantation of an acrylic (AcrySof Toric
SN60T3, SN60T4, and SN60T5) or a silicone (Staar AA4203-TF, AA4203-TL)
toric IOL but does not compare to a group receiving a non-toric IOL
Paper published in Portugese
Observational study describing the outcome after implantation of a toric IOL
(AcrySof) but does not compare to a group not receiving toric IOL implantation
Prospective, observational study describing the outcome after implantation of a
toric IOL (MicroSil 6116TU) but does not compare to a group receiving a
non-toric IOL
Observational study describing the outcome after implantation of a toric IOL
(MicroSil Toric) but does not compare to a group receiving non-toric IOL
implantation. Paper published in German
Wrong study design
Wrong comparator
Cohort study describing the outcome after impantation of a toric IOL (T-flex
623T) but does not compare to a group receiving a non-toric IOL
Retrospective case series describing outcome after implantation of AcrySof Toric
IOL
Wrong intervention
RCT. Compares Tecnis and AcrySof Toric IOLs. Does not compare to a group
not receiving a toric IOL
Wrong study design
Case report of a single patient receiving a toric IOL
Wrong comparator
Retrospective study describing the outcome after implantation of a toric IOL
(AcrySof toric) but does not compare to a group receiving a non-toric IOL
Wrong study design
Wrong intervention
Case report describing management of astigmatism with 2 toric IOLs
Prospective study describing the outcome of combined toric IOL implantation
(Staar) and relaxing incisions in reducing high preexisting astigmatism
Case report describing the management of astigmatism with 2 toric IOLs
Observational study describing the outcome after implantation of a toric IOL
(SN60TT AcrySof Toric) but does not compare to a group receiving a non-toric
IOL
Same study population as Goggin 2011, describes the outcome after
implantation of a toric IOL (SN60TT Acrysof Toric) but does not compare to a
group receiving a non-toric IOL
Observational study describing the outcome after implantation of a toric IOL
(AcrySof Toric) but does not compare to a group receiving a non-toric IOL
Wrong intervention
Wrong intervention
Case series describing the outcome after implantation of a toric IOL (AcrySof
Toric) but does not compare to a group receiving a non-toric IOL
Retrospective, interventional, case series describing the rotational stability of a
toric IOL (Staar Toric) but does not compare visual outcome/spectacle indepence
in patients receiving/not receiving a toric IOL
Partly observational and partly theoretical study evaluating the effect of axis
misalignment on postoperative refraction
Wrong study design
Wrong outcomes
Case series describing the outcome after implantation of a toric IOL in patients
who had previously undergone penetrating keratoplasty
Wrong study design
Prospective, observational study describing the rotational stability of a toric IOL
(AcrySof Toric) but does not compare visual outcome or spectacle independece
in patients receiving/not receiving a toric IOL
Prospective, observational study describing the rotational stability of a toric IOL
(AcrySof SN60TT) but does not compare visual outcome or spectacle
independece in patients receiving/not receiving a toric IOL
Wrong study design
Prospective non-randomized study comparing outcome after implantation of
AcrySof Toric or AcrySof spherical IOL
Wrong study design
Case series describing the outcome and rotational stability of a toric IOL (Staar
Toric AA-4203TF) but does not compare to a group receiving a non-toric IOL
Wrong study design
Wrong study design
Wrong study design
Wrong study design
Prospective, non-randomized, observational study comparing the outcome after
implantation of AcrySof Toric and AcrySof spherical IOL
Wrong study design
Prospective, observational study describing the outcome after implantation of
AcrySof toric IOL but does not compare to a group receiving non-toric IOL
Wrong study population
Wrong study population
Wrong study design
Retrospective study evaluating the outcome after multifocal toric IOL implantation
Wrong study design
Wrong study design
Wrong study design
Observational study describing the outcome after combined toric IOL
implantation and astigmatic keratotomy. Does not compare to a group not
receiving toric IOL implantation
Prospective study evaluating the effect of toric IOL implantation combined with
limbal relaxing incisions. Does not compare to a group not receiving toric IOL
implantation
Wrong comparator
Prospective study comparing toric and non-toric IOL implantation in patients
undergoing simulataneous phacoemulsification and 23-gauge vitrectomy. All
patients had vitreoretinal disease
Wrong comparator
Retrospective study comparing outcome after toric IOL or peripheral corneal
relaxing incisions
Retrospective case series describing the outcome after implantation of a toric
IOL (AcrySof Toric) in a teaching hospital. Does not compare to a group
receiving a non-toric IOL
Case series describing the outcome after toric IOL (AcrySof Toric) or multifocal
IOL (AcrySof Restor) implantation. Does not compare to a group receiving a
non-toric, monofocal IOL
Observational study describing the outcome after toric IOL (Staar AA4203T)
implantation. Does not compare to a group receiving a non-toric IOL
Wrong study design
Prospective, non-randomized study comparing outcome after implantion of a toric
(AcrySof Toric) or spherical (AcrySof) IOL
Wrong comparator
Wrong study design
Multicenter cohort study describing the outcome after implantation of a toric IOL
(Tecnis Toric) but does not compare to a group receiving a non-toric IOL
Case series describing the outcome after implantation with a toric IOL (Staar
AA4203TF or AA4203TL) but does not compare to a group receiving a non-toric
IOL
Retrospective chart review comparing outcome after AcrySof Toric or AcrySof
spherical IOL
Retrospective study describing the outcome after toric IOL implantation (Rayner
T models) in patients who had previously undergone penetrating keratoplasty
compared to non-keratoplasty patients. Does not compare to a group receiving a
non-toric IOL
Retrospective study describing the outcome after implantation of a toric IOL
(Staar AA4203TF) or a non-toric IOL (unknown model). The study included both
patients who underwent cataract surgery and clear lens extraction
Retrospective case series reporting the outcome after implantation of a toric IOL
(AcrySof T3-T9) but does not compare to a group receiving a non-toric IOL
Observational study describing the outcome after spherotoric IOL implantation
(Morcher BIL IOL). Does not compare to a group receiving a non-toric IOL
Wrong study design
Wrong study design
Wrong study design
Observational study evaluating the outcome after implantation of AT TORBI toric
intraocular lens. Does not compare to a group not receiving a toric IOL
Prospective, observational study describing the outcome after implantation of
different types of toric IOLs (AcrySof SN60T6, SN60t7, SN60T8 or SN60T9) but
does not compare to a group that did not receive toric IOL implantation
Cohort study describing the outcome after implantation of a multifocal IOL (AT
Lisa). Does not compare to a group receiving a non-toric or non-multifocal IOL
Observational study describing the outcome after implantation of different types
of toric IOLs (AcrySof Toric) or toric phakic IOL (Artiflex pIOL, Artisan Toric pIOL)
implantation. Does not compare to a group receiving a non-toric IOL
Wrong patient population
Wrong study design
Wrong study design
Retrospective study describing the outcome after implantation of a toric IOL
(AcrySof SA60T3, SA60T4, SA60T5) but does not compare to a group receiving
a non-toric IOL
Wrong study design
Selection bias (biased allocation to interventions) due to inadequate generation of a randomised sequence
"Each site had sealed randomization enveloped with IOL
treatment assignments enclosed... For each subject both an
AcrySof Toric and a control IOL was available before
beginning of surgery. After the surgical incision was
performed, the envelope was opened and the assigned IOL
was implanted"
Judgement Comment: Patients were randomized using a online program. s. 1464
Selection bias (biased allocation to interventions) due to inadequate concealment of allocations prior to assignment
"Intraocular lens diopter and cylinder power were calculated
for al subjects preoperatively, because IOL assignment was
not revrealed until cataract surgery was in progress"
Judgement Comment: computer generated. central allocation
Performance bias due to knowledge of the allocated interventions by participants and personnel during the study
"After ... the envelope was opened and the assigned IOL was
implanted... the investigators were no longer masked to IOL
assignment, but the subject remained masked"
Judgement Comment: The patients and investigator performing the postoperative examinations were blinded.
Detection bias due to knowledge of the allocated interventions by outcome assessors
Not reported
Judgement Comment: The investigator performing the postoperative examinations were blinded.
Attrition bias due to amount, nature or handling of incomplete outcome data
"Of the 541 enrolled subjects, 24 did not receive implants
owing to preoperative or intraoperative exclusions; 517
received the AcrySof Toric IOL (n=256) or the control IOL
(n=261). Results exclude subjects who received IOLs but discontinued (Toric n=4, control n=2) or were lost to follow-up
(Toric n=9, control n=22)" Thus, 5% in the toric and 9% in the
control group were lost after randomization. A comparison
between the lost group and the analysed group is not
provided and hence we cannot judge whether the high
number of lost subjects were likely to affect the results
Judgement Comment: Intet frafald i kontrolgruppen og 4 der falder fra i interventinsgruppen (2 dør og 2 dropouts). men der er foretaget intention to treatanalyser
Reporting bias due to selective outcome reporting
Important outcomes are reported
Judgement Comment: Protokol på clinical trials. All primary and secondary outcomes of interest are reported
Bias due to problems not covered elsewhere in the table
Industry sponsored study but not likely to affect the result
Judgement Comment: appears to be free of other sources of bias