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Laser fotopembekuan bagi retinopati diabetes proliferatif

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

Laser fotopembekuan bagi retinopati diabetes proliferatif

Soalan ulasan

Adakah laser fotopembekuan satu rawatan berkesan untuk retinopati diabetes?

Latar belakang

Retinopati diabetes (DR) adalah masalah yang biasa untuk orang dengan kencing manis dan boleh membawa kepada kehilangan penglihatan. Bahagian belakang mata (retina) boleh membangunkan masalah kerana kencing manis, termasuklah pertumbuhan salur darah baru yang berbahaya (DR proliferatif, disebut di sini sebagai 'PDR'). Laser fotopembekuan adalah rawatan yang biasa digunakan untuk DR di mana pakar mata menggunakan laser di belakang mata untuk menghentikan sebahagian daripada pertumbuhan yang membahayakan.

Ciri‐ciri kajian

Kami mendapati terdapat lima kajian. Carian dilakukan pada April 2014. Tiga kajian dilakukan di Amerika Syarikat, satu kajian di UK dan satu kajian di Jepun. Seramai 4786 orang (9503 mata) telah dimasukkan ke dalam kajian‐kajian ini. Kebanyakan peserta ini mempunyai PDR.

Hasil utama

Kami mendapati terdapat kehilangan visi sederhana pada 12 bulan adalah sama di mata yang dirawat dengan laser dengan mata yang tidak dirawat, tetapi penilaian yang dibuat kemudian menunjukkan bahawa mata yang dirawat dengan laser adalah kurang berkemungkinan untuk mengalami kehilangan penglihatan yang sederhana. Rawatan dengan laser mengurangkan risiko kehilangan penglihatan teruk dengan lebih daripada 50% pada bulan 12. Terdapat juga kesan yang sama atas proliferatif DR. Tiada satu pun kajian yamelaporkan hasil relevan pesakit seperti kesakitan atau kehilangan lesen memandu.

Kualiti bukti

Kami tidak dapat mencari banyak kajian dan yang kami dapati telah dilakukan agak lama dahulu ketika piawaian kelakuan ujian dan laporan masih rendah. Kita menilai kualiti bukti sebagai rendah, kecuali dengan keputusan bagi kehilangan penglihatan yang teruk, yang dinilai sebagai bukti kualiti sederhana.