Capítulo 1. Revisión bibliográfica sobre la gestión de los riesgos en empresas de
1.5 Procedimientos y herramientas para la Gestión de Riesgos
We included 108 primary studies (Table 47). A total of 104 studies were predominantly on people with (or at risk of) dry AMD and four studies were on people with STGD. Of the 104 dry AMD studies, there were 26 of pharmacological treatments, 30 in physical therapies, three of cell transplants and 45 of nutritional supplements. In the four studies in STGD there were two physical therapies and two nutritional
TABLE 47 Studies and interventions included in the systematic review
Primary reference Intervention(s) STGD
Alemanet al., 2007114 Lutein
Querqueset al., 2010125 Nutritional supplements Röcket al.2013121 Electrotherapy Teussinket al., 2015122 Light protection Dry AMD Physical therapies Krennet al., 2008152 Acupuncture Pipiset al., 2015162 Blue-light filters
Lavric & Pompe 2014164
Blue-light filters Nagaiet al., 2015163
Blue-light filters Chonget al., 2011 (abstract)165
Blue-light filters
Blahaet al., 2013179 Haemopheresis
Studnicˇkaet al.2013180 Haemopheresis Klingelet al., 2010181 Haemopheresis Kosset al., 2009175 Haemopheresis
Pulidoet al., 2006174 Haemopheresis
Rencováet al., 2015177
Haemopheresis Brunneret al., 2000170
Haemopheresis Swartz and Rabetoy 1999178
Haemopheresis Figueroaet al., 1997239 Laser photocoagulation
Guymeret al., 2014232 Laser Ivandicet al., 2008237 Laser Luttrullet al., 201696 Laser
Huanget al., 2011223 Laser
Prahset al., 2010236 Laser Merryet al., 2016238 Photobiomodulation Shinodaet al., 2008199 Microcurrent
Chaikinet al., 2015198 Microcurrent
Kondrotet al., 201597 Microcurrent Kondrotet al., 2002208 Microcurrent Anastassiouet al., 2013196 Microcurrent
Michaelet al., 1993204 Microcurrent
Borrelliet al.2012248 Oxygen ozone-therapy Bocciet al., 2011244 Ozone Hudsonet al., 2006250 Telescopes
Qureshiet al., 2015254 Telescopes
TABLE 47 Studies and interventions included in the systematic review (continued) Primary reference Intervention(s)
Cell transplant technologies
Schwartzet al., 2015123
RPE transplant Songet al., 2015271
Stem cell transplant
Hoet al., 2017276 Cell transplants
Pharmacological therapies
Augustinet al.2013325
Alprostadil
Ladewiget al., 2005326 Alprostadil
Remkyet al., 2005328 Dorzolamide
Yehoshuaet al., 2014323
Eculizumab Dugalet al., 2015308
Emixustat
Mataet al., 2013144 Fenretide
Landaet al., 2011330 Glatiramer acetate
Brilliantet al., 2016324
L-dopa Zhanget al., 2011273
NT-501
Wonget al., 201092 Topical OT-551
Vojnikovic´et al., 2008334 Prednisolone
Gallego-Pinazoet al., 2011338
Ranibizumab Petrouet al., 201594
Sirolimus
Wonget al., 2013332 Sirolimus
Maguireet al., 2009293 Statins
Al-Holou 2015291
Statins Barbosaet al., 2014294
Statins
Vavvaset al., 2016286 Statins
McGwinet al., 2003295 Statins VanderBeeket al., 2013296 Statins Kaisermanet al., 2009297 Statins
Fonget al., 2010298 Statins
Etminanet al., 2008285 Statins+ACE inhibitor
Jaffeet al., 2015190
Tandospirone Cohenet al., 2012335
Trimetazidine
Kaiseret al., 1995336 Visaline
Nutritional supplements AREDS 132
Antioxidants and zinc
AREDS 2348 Antioxidants, carotenoids and fatty acids
Berrowet al., 2013362 Lutein
Murrayet al., 2013363
Lutein Weigertet al., 2011364
Lutein, lutein+zeaxanthin Maet al., 2012a366 Lutein, zeaxanthin
TABLE 47 Studies and interventions included in the systematic review (continued) Primary reference Intervention(s) Huanget al., 2015a192 Lutein, zeaxanthin
Kellyet al., 2014372 Lutein, zeaxanthin
Kellyet al., 2017378
Lutein eggs Richeret al., 2011367
Lutein, zeaxanthin Akuffoet al., 2015368 Lutein, zeaxanthin
Penget al., 2016369 Lutein, zeaxanthin
Wuet al., 2015370
Lutein, zeaxanthin Trieschmannet al., 2007373
Lutein, zeaxanthin
Arnoldet al., 2013371 Lutein, zeaxanthin, long-chain PUFA
Robmanet al., 2007374 Lutein, zeaxanthin
Vishwanathanet al., 2009376
Eggs (lutein, zeaxanthin) Olket al., 2015375
Triple therapy, zeaxanthin Beattyet al., 2013354 Lutein, zeaxanthin+others
Bartlettet al., 2007377
Lutein, antioxidants Richeret al.2004379
Lutein+carotenoids, antioxidants, vitamins, minerals Dawczynskiet al., 2013380
Lutein, zeaxanthin, omega-3 García-Layanaet al., 2013381 Lutein and DHA
Wolf-Schnurrbuschet al., 2015365 Lutein, omega
Piermarocchiet al., 2012382
Lutein, zeaxanthin Reynoldset al., 2013402
Omega-3
Feheret al., 2005400 Antioxidant and fatty acid
Souiedet al., 2013393 DHA
Taoet al., 2016401
Alpha lipoic acid Cougnard-Grégoireet al., 2016403
Olive oil
Christenet al., 2009406 Vitamin B
6, B12, folate
Merleet al., 2016407 Folate and vitamin B 12
Gopinathet al., 2013408
Serum homocysteine, folate and vitamin B12
Christenet al., 2007398
Beta-carotene
Christenet al., 2010412 Vitamin E
Christenet al., 2014410 Multivitamins
Cangemiet al., 2007411
Antioxidant and omega 3 Tayloret al., 2002399
Vitamin E
Teikariet al., 1998397 Antioxidants
Ahmadiet al., 2009415 HESA-A
Riaziet al., 2017422
Saffron Lashayet al., 2016421
Saffron
Piccardiet al., 2012420 Saffron
Falsiniet al., 2010417
Saffron Marangoniet al., 2013418
Saffron
supplements. Two studies had subgroups of people with dry AMD and STGD,97,98making a total of six studies in STGD (seeTable 47).
Summary overview of the study characteristics can be seen inReport Supplementary Material 6. There was a range of study designs, with 60 RCTs and CCTs, 24 cohort studies and cross-sectional studies, 13 single-arm before-and-after studies, 5 case–control studies and 6 case series. Many studies had small sample sizes, the durations of intervention and follow-up were often short, and there were differences in the outcomes reported. Further details are provided inChapters 2–7. Baseline characteristics of participants are summarised inReport Supplementary Material 6. There was generally poor reporting of baseline characteristics across the studies. The risk of bias of RCTs and CCTs and quality of non-randomised studies are summarised inReport Supplementary Material 6. The overall quality of each study are reported within the results chapters of this report.
Review methods
Inclusion and exclusion criteria
Participants
l People with a confirmed diagnosis of dry AMD or STGD.
Interventions
l Any interventions which aim to preserve or restore vision in dry AMD or STGD.
Clinical experts were asked to identify treatments in development to ensure that all potential treatments were included in the review.
Exclusions: to avoid overlap we excluded studies on some interventions being reviewed in the NICE guideline process (e.g. smoking cessation, diagnostic technologies, monitoring and review, and rehabilitation support). Outcomes
Primary outcomes were those that matter to patients and included:
l visual acuity
l contrast sensitivity
l macular sensitivity
l adverse effects of treatment
l adherence to treatment
l reading speed
l ability to drive
l health-related quality of life
l progression of disease.
Although visual outcomes were preferred, because progression of dry AMD is slow we also included secondary outcomes where there was good evidence that they are strong predictors of subsequent visual outcomes. Secondary outcomes that were potentially eligible included:
l rod function (may not correlate with VA as central VA, as measured using VA charts, but depends on foveal function, and the fovea is cone rich. Rod function is one of the earliest abnormalities detected in people who will later develop GA in AMD)
l macular function as measured by microperimetry
l RPE thickness
l AF
l drusen volume. Design
l Randomised controlled trials.
l Controlled clinical trials with a concurrent control group.
l Observational studies.
Exclusions: we excluded observational studies with<10 participants (or eyes) with the exception in studies for STGD and studies in stem cell treatments.
Systematic reviews and literature reviews that were identified by the searches were assessed for quality and summarised if they met quality criteria. Where there was a good-quality systematic review we did not review the primary studies. Reviews were also used as a source for identifying primary studies. Study selection and data extraction
Studies were selected for inclusion through a two-stage process using predefined and explicit criteria. Titles and abstracts from the full literature search results were screened independently by two reviewers to identify all citations that appeared likely to have met the inclusion criteria. Full manuscripts of relevant studies were then retrieved and assessed for eligibility by one reviewer and checked by a second reviewer. Studies published as abstracts or conference presentations were only included if sufficient details were presented to allow an appraisal of the methodology and the assessment of results to be undertaken. As far as possible, full papers or abstracts describing the same study were linked together, with the article reporting key outcomes designated as the primary publication.
Data were extracted by one reviewer using a standard data extraction form and checked by a second reviewer. At each stage, any disagreements between reviewers were resolved by consensus or if necessary by arbitration by a third reviewer.
Method of data synthesis
Studies were synthesised through a narrative review with tabulation of results of included studies. Formal synthesis through meta-analysis was not possible because studies were not of sufficient quality and were heterogeneous in terms of participant characteristics, outcomes and study design.