Late In-the-bag intraOcular Lens dislocatioN Surgery: A Randomized Clinical Trial (LION Trial)
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Inflammation in the anterior chamber after surgery
研究概览
简要总结
Overall aim of the study is to compare the safety and efficacy of two different surgical methods to treat Late In-the-bag intraocular lens dislocation.
详细描述
Cataract is a condition of unclear lens that cause poor vision. The only treatment is surgery where the blurred biological lens is replaced with an artificial clear lens (IOL). Most people who operate achieve full vision. Nevertheless, serious complications may occasionally occur, and one of these is dislocation of the entire complex with IOL and lens capsule. This requires surgical treatment.
In this study the investigators want to compare two different surgical methods used in late dislocation of IOL inside the capsule after cataract surgery. Patients will be randomly affiliated to either the suturing of existing IOL / capsule complex, or lens exchange to an IOL fixed to the iris.
The focus of the trial will be especially on complications and other eye changes in the early stages of surgery. Today, little data is available on these topics, and the investigators believe that new knowledge can bring us closer to a response to preferred operating techniques and an optimal drug drop regime for the patient group.
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 (Outcomes Assessor)
盲法说明
Masking of research optometrists to group affiliation at the postoperative examinations will be endeavored. A physician will perform slit lamp examinations at the postoperative visits, hence he/she cannot be masked, nor can the surgeon. The investigator will be masked during the image analysis.
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •IOL inside the capsule ("in-the-bag")
- •Late dislocation (more than 6 months after cataract surgery)
- •IOL visible in the pupillary area in the supine position and hence possible to perform surgery with an anterior approach
- •Eligibility for both operation methods
- •Ability to cooperate fairly well during the examinations
- •Willing to participate in the study, e.g. willingness to participate at all control visits
排除标准
- •IOL designs that cannot be repositioned with a suture loop, such as plate-haptic IOLs without holes in the peripheral part
- •Eyes with especially thin sclera
- •Active uveitis or pronounced iris pathology
- •Eyes with previously performed Descemet's Stripping Automated Endothelial Keratoplasty (DSAEK)
- •Totally dislocated IOL into the posterior segment of the eye requiring pars plana vitrectomy
- •Eyes that prior to cataract extraction had a subluxated lens in need of surgery with a Cionni capsular tension ring (e.g. patients with Marfan syndrome and ectopia lentis)
- •Cases requiring a change in refraction. Risk of severe anisometropia
- •Patients unable to lie in supine position for surgery in local anesthesia, e.g. severe chronic obstructive pulmonary disease and severe heart failure
- •Patients using anticoagulants that cannot be discontinued
- •For patients with dislocated IOLs in both eyes during the study period, only the first operated eye will be included. Patients without prospects of improvement in vision will be excluded.
研究组 & 干预措施
IOL exchange group
干预措施: IOL exchange (Procedure)
IOL repositioning group
干预措施: IOL repositioning (Procedure)
结局指标
主要结局
Inflammation in the anterior chamber after surgery
时间窗: The first weeks after surgery
Measured with a Laser Flare Meter
Changes in macular thickness and occurrence of Cystoid macular edema
时间窗: The first months after surgery, and long term changes months up to two years after surgery
Evaluated with Optical Coherence Tomography
Intraocular pressure changes
时间窗: Early changes in the first weeks after surgery, and long term changes months up to two years after surgery
Measured with Goldmann Applanation Tonometry and iCare, both measured in mmhg
次要结局
- Endothelial cells(Short term (2 weeks) and long term (6months and 2 years))
- Intra- and postoperative complications(Short term and long term (first post operative day, the first weeks and months, and up to two years))
- Best Corrected Visual acuity (BCVA)(Short term (the first weeks and up to 6 months) and long term (up to two years))
- Glare(Medium term (6 months))
- IOL tilt(6 months and 2 years)
- Refractive outcomes - subjective refraction measured with a phoropter(Short term - meaning 2 weeks to 6 months. Long term - meaning up to two years)
- Astigmatism(Short term - meaning 2 weeks to 6 months. Long term - meaning up to two years)
研究者
Marius Dalby
Principal Investigator, M.D., PhD Candidate
Oslo University Hospital