Precision of 2D vs 3D Low Energy Femto-LASIK: Intraoperative and Postoperative OCT-based Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- Predictability of central flap thickness in OCT-controlled 110 µm LASIK
研究概览
简要总结
The aim of this study was to test the hypothesis that OCT-guided 110 µm targeted flaps will result in accurate, predictable, and precise thickness flaps, with low complication rates when performed and compared using both 2D and 3D flap geometry applications and how it correlated to visual experience and quality of life responses during the early postoperative period.
详细描述
It has been postulated that it is possible with the Ziemer Femtosecond LDV laser system to create reproducible flaps in terms of thickness and predictability. The aim of this study was to test the hypothesis that OCT-guided 110 µm targeted flaps will result in accurate, predictable, and precise thickness flaps, with low complication rates when performed and compared using both 2D and 3D flap geometry applications. Patient-reported outcomes are increasingly incorporated into clinical trials as they provide access to valuable information on the physical experience of the patient during and after the treatment. A questionnaire will therefore also be introduced in this study to evaluate how well self-reported pain, visual experience, and quality of life responses are correlated with flap geometries in both groups during the early postoperative period. The study holds direct medical benefit to the patient in this that they received an immediate improvement in his/her unaided vision. Moreover, the patient's participation contributes to the medical knowledge about the use of femtosecond lasers for refractive surgery, in particular in view of the use of intraoperative OCT visualization tools. The patients will gain access to the newest technology available for refractive surgery namely a low pulse energy high-frequency femtosecond laser.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •as described by the German Commission for Refractive Surgery (KRC) are:
- •The recommended range of application for the correction of myopia is up to -8.00 D and for the correction of astigmatism up to 5.00 D.
- •The limited for LASIK correction of myopia is up to -10.00 D and correction of astigmatism up to 6.00 D. If myopic astigmatism is to be corrected, the values for myopia and astigmatism must be added together.
- •The recommended range for correction of hyperopia is up to 3.00 D. Up to 4.00 D is the range of limited application for hyperopia.
- •Age ≥18 years with stable eyesight for over 12 months.
排除标准
- •as described by the German Commission for Refractive Surgery (KRC):
- •preoperative corneal thickness less than 480 μm
- •predicted stromal thickness under the flap after ablation of less than 250 μm
- •chronic progressive corneal disease and forme fruste keratoconus
- •surgery before the age of 18 years
- •symptomatic cataract
- •Glaucoma with a marked loss of visual field
- •Exudative macular degeneration.
- •Concurrent participation in another ophthalmological clinical study
- •Exclusion criteria irrespective of the KRC criteria:
- •Undergone former eye surgery
- •Contact lens wear within the two weeks prior to commencement of preoperative measurements
研究组 & 干预措施
2D LASIK
With the 2D method, the flap resection is created in a planar mode (xy-plane), without vertical cut, at the requested depth.
干预措施: 2D and 3D cutting method using a low energy Femtosecond laser LDV Z8 for LASIK flap cutting (Device)
3D LASIK
With the 3D method, the flap resection is done in a three-dimensional mode, at the requested depth, with the requested diameter and the desired border (side cut) angle
干预措施: 2D and 3D cutting method using a low energy Femtosecond laser LDV Z8 for LASIK flap cutting (Device)
结局指标
主要结局
Predictability of central flap thickness in OCT-controlled 110 µm LASIK
时间窗: 1 month postoperatively
Analyze central flap thickness in OCT-controlled 110 µm LASIK and to report on intended versus achieved flap thickness of one group with a 2D flap geometry in one eye and another group with a 3D flap geometry in the contralateral eye. All OCT measurements will be done in micron metres (µm).
次要结局
- Postoperative planarity(1 week, 1 month)
- Intraoperative flap morphology(During surgery)
- Patient reported Outcomes: early recovery period(1 day, 2Day, 1 week follow up)
- Postoperative flap properties(1 week, 1 month)
- Visual outcomes(1 day, 1 week, 1 month)
- Comparison of intraoperative flap thickness with pre- and postoperative results(1 week, 1 month)
- Complications(Intra- and postoperatively up to 1 month follow up)