The Individually-Marked Panretinal Laser phoTocoagulation for Proliferative Diabetic Retinopathy Study: IMPETUS 2018 - TREAT
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 53
- 试验地点
- 2
- 主要终点
- Need for retreatment between the groups
研究概览
简要总结
Background Diabetic eye disease is the most frequent complication among the 320,000 Danes with diabetes. The formation of new vessels (PDR) in the inner part of the eye (retina) is a feared complication and a leading cause of blindness, since these vessels are fragile and often cause bleeding within the eye. Peripheral retinal laser treatment (PRP) halves the risk of blindness, but often comes with a high prize. The peripheral part of the retina is responsible for the visual field and the night vision, and PRP limits these abilities (i.e. loss of driving license).
The technique of PRP has principally been the same for the past 40 years with standard treatment given for all patients. With this one size fits all approach, a substantial number of patients will either be treated too much or too little. Too little treatment is inefficient, and disease progression may occur. Excessive treatment may cause side effects like loss of visual fields and decreased night vision. Therefore, it is important to test if treatment can be applied on an individual basis to give high efficacy treatment with minimal side effects.
IMPETUS 2018 - TREAT is the second of two studies aimed at making an individual design for retinal laser treatment. In IMPETUS 2018 - DETECT the investigators demonstrated that non-invasive examinations of the oxygen level and measurements of the retinal vascular tree provide important information of individual treatment response. For instance, if standard PRP led to three per cent higher retinal oxygen saturation, there was a 4-fold risk of disease progression despite treatment. Hence, such a patient would benefit from more treatment to avoid blindness. With these observations at hand, the investigators want to compare a less invasive treatment (individualized laser treatment) against the standard PRP.
Another essential aspect in the treatment of PDR is to be able to give the right diagnosis and to evaluate the efficacy of laser treatment. So far, this has been performed by fluorescein angiography. However, this examination are highly person-dependent and unpleasant to patients, and a more objective approach is needed. Optical coherent tomography angiography (OCT-A) is a quick, noninvasive scanning of the retina which is ideal to visualize moving objects like blood within the retinal vessels. The method has been successfully implemented in a number of retinal diseases, but it has never been validated in PDR.
Standard PRP is often performed in 3-4 sessions. However, it may be painful, and patients sometimes choose not to complete all sessions after the initial treatment has been given. There is insufficient knowledge of the patient-barriers to treatment, and it is important to address these in an individualized treatment design.
Aim In this 6-month 1:1 randomized, prospective study the investigators want to investigate 1) whether individualized retinal laser treatment compared with standard PRP has the same efficacy but less side effects, 2) whether OCT-A can be used as an objective marker for disease activity, and 3) to obtain a better understanding of patient-reported barriers to standard laser treatment PRP and whether these can be addressed with personalized retinal laser treatment.
Setup Fifty eight consecutively recruited patients (1 May 2017 - 30 April 2018) with newly diagnosed PDR referred to the Department of Ophthalmology, OUH, and randomly assigned to standard PRP (n=29) or individualized laser treatment (n=29).
Intervention Standard laser treatment is performed in all four quadrants of the retina. Individualized laser treatment is only performed in the part(s) of the retina with proliferation(s).
Both treatments are carried out at baseline (BL), and additional treatment is given at month three (M3) and/or (M6), if necessary.
Investigations Retinal digital images, fluorescein angiography, OCT-A (BL, M3, M6). Test of visual fields, dark adaptation and quality of life (BL, M6). Semi-structured interview will be performed with five patients who have received PRP in one eye and individualized laser treatment in the other eye. This will address treatment experience, potential barriers to treatment, etc.
What to measure:
Differences in need for retreatment, night blindness, visual fields, visual acuity, bleeding in the eye, surgery, and quality of life between the groups.
详细描述
Introduction Diabetes mellitus is an epidemic disorder, which in Denmark alone is affecting 320,000 patients. Diabetic retinopathy (DR) is the most frequent long term complication to diabetes mellitus (1) and a feared cause of severe vision loss and blindness (2).
Proliferative diabetic retinopathy (PDR) is the major cause of severe visual loss. Lack of oxygen to the retina (retinal ischemia) results in up-regulation of, in particular, the growth factor vascular endothelial growth factor (VEGF) (3) followed by compensatory retinal proliferations. The neovasculature is fragile and often leads to vitreous hemorrhages or retinal detachment which makes the patient at high risk of irreversible vision loss (4).
In 1976 it was shown that patients with severe PDR can halve the risk of severe vision loss by peripheral retinal laser treatment (photocoagulation panretinal, PRP) (5). This treatment reduces the retina's oxygen demand, which makes the VEGF concentration decrease and the proliferations shrink (5).
PRP has largely been the same for the last 40 years. The standard treatment is basically the same for all patients (4 + 6), which leads to some patients being either over or under treated. If treatment is inadequate, patients are in risk of disease progression and thus difficult vision loss (7). On the other hand, the treatment may cause side effects in the form of loss of visual field (8-9), night vision loss (10) and accumulation of fluid in the eye's macula (diabetic macular edema) (11).
This study is a continuum of the clinical project IMPETUS 2018 - DETECT, which aimed to identify the factors that were important for a successful PRP treatment of PDR. In the study the investigators prospectively followed 65 patients with newly diagnosed PDR. All patients received baseline navigated PRP, as in Scandinavia only offered at Odense University Hospital (OUH). Navigated panretinal laser with a Navilas® laser ensures optimized treatment (12), shorter treatment (13) and increased patient comfort (12-14). Treatment effect was investigated at month three and six, and if necessary, treatment was supplied. All the patients venous retinal oxygen saturation was measured to study whether this had any therapeutic value.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diabetes mellitus.
- •Newly diagnosed, untreated PDR in one eye (the possibility of inclusion of both eyes by bilateral PDR).
排除标准
- •Diabetic macular edema in the affected eye.
- •Age <18 years.
- •Pregnancy.
- •Ambiguities in refracting media on topical eye.
研究组 & 干预措施
Standard Panretinal Photocoagulation
Localized to all four retinal quadrants.
干预措施: Panretinal Photocoagulation (Procedure)
Individ. Panretinal Photocoagulation
Localized to only the affected quadrants.
干预措施: Panretinal Photocoagulation (Procedure)
结局指标
主要结局
Need for retreatment between the groups
时间窗: At month 3 and 6
Change in the progression of PDR, hence the difference in the need for retreatment between the standard laser treatment group vs. the individualized laser treatment group.
Change in dark adaptation between the groups
时间窗: From baseline to month 6
Change in dark adaptation between the standard laser treatment group vs. the individualized laser treatment group.
Sensitivity and specificity of OCT angiography as an expression of disease activity in PDR
时间窗: At month 6
The specificity and sensitivity of OCT-A in detecting progression in PDR
Loss of visual fields between the groups
时间窗: From baseline to month 6
Loss of visual field between the standard laser treatment group vs. the individualized laser treatment group.
次要结局
- Change in visual acuity between the groups(From baseline to month 6)
- Need for surgical removal of the vitreous between the groups(From baseline to month 6)
- Difference in proportion with the development of vitreous haemorrhage between the groups(From baseline to month 6)
- Change in quality of life between the groups(From baseline to month 6)
研究者
Anna Stage Vergmann
Ph. D. student
Odense University Hospital