[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????
Study design: Randomized controlled trial
Study grouping: Parallel group
Baseline Characteristics
Intervention
Kontrol
Overall
Included criteria: Bilateral senile cataract and preexisting regular topographic corneal astigmatism demanding a toric IOL implantation, with cylindric values between 1.5D and 6.0D
Excluded criteria: Pregnancy, lactation, irregular corneal astigmatism, diabetic retinopathy, iris neovascularization, congenital eye abnormality, glaucoma, pseudoexfoliation syndrome, amblyopia, ubeitis, long-term anti-inflammatory treatment, advanced age-related macular degeneration, retinal detachment, previous ocular surgery, severe corneal and retinal disease, and history of eye trauma.
Pretreatment: No of males not available
Intervention Characteristics
Intervention
Kontrol
Brilleafhængighed (afstand)
Antal patienter der ikke opnåede postop UCDVA 0.8 (snellen) eller bedre (mean SD)
Antal patienter der ikke opnåede postop UCDVA 0.8 (snellen) eller bedre
Antal komplikationer
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: For subjects with cataracts in both eyes, the eye with the worse BCDVA at the preoperative visit was designated the study eye. Only one eye per subject was enrolled in the study .minimum preoperative corneal astigmatism of 0.90D and a predicted postoperative corneal astigmatism between 0.90 and 2.40D, when taking surgically induced astigmatism into account.
Excluded criteria: n/a
Pretreatment:
Intervention Characteristics
Intervention
Kontrol
Brilleafhængighed (afstand)
Antal patienter der ikke opnåede postop UCDVA 0.8 (snellen) eller bedre (mean SD)
Antal patienter der ikke opnåede postop UCDVA 0.8 (snellen) eller bedre
Antal komplikationer
NKR 04 Grå stær on 07/05/2019 22:28
Study Design
Kun pt. ml. 0.90-1.39D er blevet randomiseret, resten har modtaget torisk iol
Study design: Randomized controlled trial
Study grouping: Parallel group
Baseline Characteristics
Intervention
Kontrol
Overall
Included criteria: pre-existing cornealastigmatism and cataracts for which uncomplicated phacoemulsi-fication surgery and IOL implantation were planned. Eligiblepatients had preoperative regular corneal astigmatism requiringcorrection of 0.75 to 3.62 D at the corneal plane in 1 or both eyes,required a spherical equivalent lens power betweenþ15.0andþ28.0 D, and had a projected postoperative best-correcteddistance visual acuity (BCDVA) of 20/30 or better.
Excluded criteria: Exclusioncriteria included irregular corneal astigmatism; pharmacologicallydilated pupil size less than 5.5 mm or pupillary abnormalities; orany ocular or systemic medications, pathologic features, abnor-malities, or diseases that would affect corneal topography, visualacuity, or operative risk.
Pretreatment:
Intervention Characteristics
Intervention
Kontrol
Brilleafhængighed (afstand)
Antal patienter der ikke opnåede postop UCDVA 0.8 (snellen) eller bedre (mean SD)
Antal patienter der ikke opnåede postop UCDVA 0.8 (snellen) eller bedre
Antal komplikationer
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
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
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
Judgement Comment: No information of how the allocation sequence was genrated
"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: No information of how the allocation sequence was generated
Judgement Comment: No information of how the allocation sequence was generated
Selection bias (biased allocation to interventions) due to inadequate concealment of allocations prior to assignment
Judgement Comment: no information
"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: No information
Judgement Comment: No information
Performance bias due to knowledge of the allocated interventions by participants and personnel during the study
Judgement Comment: No information
"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: No information
Judgement Comment: No information
Detection bias due to knowledge of the allocated interventions by outcome assessors
Judgement Comment: No information
Not reported
Judgement Comment: No information
Judgement Comment: All examiners were masked
Attrition bias due to amount, nature or handling of incomplete outcome data
Judgement Comment: Ingen oplysninger om frafald
"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: No information
Judgement Comment: A total of 269 subjects were implanted in the study with 197 in theRCA (102 implanted with the ZCT150 and 95 implanted with theZCB00) and 72 in the Open Label arm.6 subjects in the RCA were randomized butnot implanted. Ved ikke hvilken gruppe de var randomiseret til.At 6 months, data were available for 101 ZCT150subjects (1 subject moved out of state) and 93 ZCB00 subjects(2 subjects died of reasons unrelated to cataract surgery and IOLimplantation)
Reporting bias due to selective outcome reporting
Judgement Comment: No information af a protocol. Kan ikke afklare om alle forventede outcomes er rapporteret. Der er ikke rapporteret komplikationer.
Important outcomes are reported
Judgement Comment: Clinicaltrials.gov NCT01852084, protokol supplied. Kan dog ikke ses: This trial has been identified as being associated with a clinical device that has not been approved or cleared by the US Food and Drug Administration. Under the terms of US Public Law 110-85, Title VIII, Section 801, the details of this study are not available to the public.2/3 af vores outcomes rapporteret.
Judgement Comment: alle outcomes of interest er rapporteret
Bias due to problems not covered elsewhere in the table
Judgement Comment: appears to be free from other bias
Industry sponsored study but not likely to affect the result
Judgement Comment: Forfatterne var enten ansat eller konsulenter hos Bausch & Lomb, der har produceret den Toriske IOL, der blev testet.
Judgement Comment: appears to be free of other sources of bias