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Laserska fotokoagulacija za proliferativnu dijabetičku retinopatiju

Abstract

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Background

Diabetic retinopathy is a complication of diabetes in which high blood sugar levels damage the blood vessels in the retina. Sometimes new blood vessels grow in the retina, and these can have harmful effects; this is known as proliferative diabetic retinopathy. Laser photocoagulation is an intervention that is commonly used to treat diabetic retinopathy, in which light energy is applied to the retina with the aim of stopping the growth and development of new blood vessels, and thereby preserving vision.

Objectives

To assess the effects of laser photocoagulation for diabetic retinopathy compared to no treatment or deferred treatment.

Search methods

We searched CENTRAL (which contains the Cochrane Eyes and Vision Group Trials Register) (2014, Issue 5), Ovid MEDLINE, Ovid MEDLINE In‐Process and Other Non‐Indexed Citations, Ovid MEDLINE Daily, Ovid OLDMEDLINE (January 1946 to June 2014), EMBASE (January 1980 to June 2014), the metaRegister of Controlled Trials (mRCT) (www.controlled‐trials.com), ClinicalTrials.gov (www.clinicaltrials.gov) and the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP) (www.who.int/ictrp/search/en). We did not use any date or language restrictions in the electronic searches for trials. We last searched the electronic databases on 3 June 2014.

Selection criteria

We included randomised controlled trials (RCTs) where people (or eyes) with diabetic retinopathy were randomly allocated to laser photocoagulation or no treatment or deferred treatment. We excluded trials of lasers that are no longer in routine use. Our primary outcome was the proportion of people who lost 15 or more letters (3 lines) of best‐corrected visual acuity (BCVA) as measured on a logMAR chart at 12 months. We also looked at longer‐term follow‐up of the primary outcome at two to five years. Secondary outcomes included mean best corrected distance visual acuity, severe visual loss, mean near visual acuity, progression of diabetic retinopathy, quality of life, pain, loss of driving licence, vitreous haemorrhage and retinal detachment.

Data collection and analysis

We used standard methods as expected by the Cochrane Collaboration. Two review authors selected studies and extracted data.

Main results

We identified a large number of trials of laser photocoagulation of diabetic retinopathy (n = 83) but only five of these studies were eligible for inclusion in the review, i.e. they compared laser photocoagulation with currently available lasers to no (or deferred) treatment. Three studies were conducted in the USA, one study in the UK and one study in Japan. A total of 4786 people (9503 eyes) were included in these studies. The majority of participants in four of these trials were people with proliferative diabetic retinopathy; one trial recruited mainly people with non‐proliferative retinopathy. Four of the studies evaluated panretinal photocoagulation with argon laser and one study investigated selective photocoagulation of non‐perfusion areas. Three studies compared laser treatment to no treatment and two studies compared laser treatment to deferred laser treatment. All studies were at risk of performance bias because the treatment and control were different and no study attempted to produce a sham treatment. Three studies were considered to be at risk of attrition bias.

At 12 months there was little difference between eyes that received laser photocoagulation and those allocated to no treatment (or deferred treatment), in terms of loss of 15 or more letters of visual acuity (risk ratio (RR) 0.99, 95% confidence interval (CI) 0.89 to 1.11; 8926 eyes; 2 RCTs, low quality evidence). Longer term follow‐up did not show a consistent pattern, but one study found a 20% reduction in risk of loss of 15 or more letters of visual acuity at five years with laser treatment. Treatment with laser reduced the risk of severe visual loss by over 50% at 12 months (RR 0.46, 95% CI 0.24 to 0.86; 9276 eyes; 4 RCTs, moderate quality evidence). There was a beneficial effect on progression of diabetic retinopathy with treated eyes experiencing a 50% reduction in risk of progression of diabetic retinopathy (RR 0.49, 95% CI 0.37 to 0.64; 8331 eyes; 4 RCTs, low quality evidence) and a similar reduction in risk of vitreous haemorrhage (RR 0.56, 95% CI 0.37 to 0.85; 224 eyes; 2 RCTs, low quality evidence).

None of the studies reported near visual acuity or patient‐relevant outcomes such as quality of life, pain, loss of driving licence or adverse effects such as retinal detachment.

We did not plan any subgroup analyses, but there was a difference in baseline risk in participants with non‐proliferative retinopathy compared to those with proliferative retinopathy. With the small number of included studies we could not do a formal subgroup analysis comparing effect in proliferative and non‐proliferative retinopathy.

Authors' conclusions

This review provides evidence that laser photocoagulation is beneficial in treating proliferative diabetic retinopathy. We judged the evidence to be moderate or low, depending on the outcome. This is partly related to reporting of trials conducted many years ago, after which panretinal photocoagulation has become the mainstay of treatment of proliferative diabetic retinopathy.

Future Cochrane Reviews on variations in the laser treatment protocol are planned. Future research on laser photocoagulation should investigate the combination of laser photocoagulation with newer treatments such as anti‐vascular endothelial growth factors (anti‐VEGFs).

PICO

Population
Intervention
Comparison
Outcome

El uso y la enseñanza del modelo PICO están muy extendidos en el ámbito de la atención sanitaria basada en la evidencia para formular preguntas y estrategias de búsqueda y para caracterizar estudios o metanálisis clínicos. PICO son las siglas en inglés de cuatro posibles componentes de una pregunta de investigación: paciente, población o problema; intervención; comparación; desenlace (outcome).

Para saber más sobre el uso del modelo PICO, puede consultar el Manual Cochrane.

Plain language summary

Laserska fotokoagulacija za proliferativnu dijabetičku retinopatiju

Istraživačko pitanje

Je li laserska fotokoagulacija učinkovita terapija za dijabetičku retinopatiju?

Dosadašnje spoznaje

Dijabetička retinopatija (DR) je čest problem za bolesnike sa dijabetesom i može dovesti do gubitka vida. Dijabetes može razviti promjene na pozadini oka (mrežnici), uključujući i rast novih štetnih krvnih žila (proliferativna dijabetička retinopatija ‐ PDR). Laserska fotokoagulacija je čest način liječenja DR u kojemu oftalmolog koristi laser da na pozadini oka zaustavi neke od štetnih promjena.

Obilježja studija

Pronađeno je 5 studija. Literatura je pretražena u travnju 2014. Tri studije provedene su u SAD‐u, jedna u Ujedinjenom Kraljevstvu i jedna u Japanu. U studiju je uključeno ukupno 4786 bolesnika (9503 očiju). Većina bolesnika imala je PDR.

Ključni rezultati

Pronađeno je da je umjerni gubitak vida nakon 12 mjeseci sličan na očima koje su liječene laserom i onima koje nisu, međutim slične analize provedene za vrijeme nakon 12 mjeseci pokazale su da će oči koje su liječene laserom imati manju šansu za nastanak umjerenog gubitka vida. Liječenje laserom smanjilo je rizik od nastanka ozbiljnog gubitka vida preko 50% za 12 mjeseci. Sličan učinak uočen je i na napredovanje DR. Ni jedna od ovih studija nije navela nuspojave važne za pacijenta kao što su bol i gubitak vozačke dozvole.

Kvaliteta dokaza

Nije pronađeno mnogo studija, a one koje su pronađene provedene su prije mnogo vremena kada su standardi provođenja istraživanja i njihovi opisi bili lošiji. Kvaliteta dokaza je loša, osim za rezultate ozbiljnog gubitka vida, za koje se smatra da su umjerene kvalitete.