Comparison of the Outcome of Topography Modified Refraction Correction to Standard Clinical Refraction Correction in Myopic Astigmatic Topography-guided LASIK
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- post operative residual astigmatism
研究概览
简要总结
Background and Rationale:
LASIK has been among the highest satisfaction rates of surgical procedures, ranging from 82%-98%. Different ablation profiles have been developed over the years. The purpose of this study is to validate this novel measurement by comparing the visual outcomes when the TMR is used in myopic astigmatic LASIK to using the standard manifest refraction or the Topolyzer measurements alone.
Objectives :
To evaluate the safety, efficacy and predictability of topography-guided myopic LASIK with three different refraction treatment strategies.
详细描述
Candidates for refractive surgery above 18 years with myopic astigmatism and no previous ocular surgery.
Sample size 60 eyes. surgery:
- 60 eyes of myopic topography-guided LASIK procedures with the same refractive platform (FS200 femtosecond to create a flap between90: 110 μm with diameter 8:9 mm and EX500 excimer lasers) will be randomized for treatment as follows:
- Group A: 20 eyes will be treated using Contoura vision with the standard manifest refraction.
- Group B: 20 eyes will be treated with Contoura vision using the topographic astigmatic power and axis and without change in the spherical power (using the same spherical power as the manifest refraction).
- Group C [TMR]: 20 eyes will be treated with Contoura vision using the topographic astigmatic power and axis and modifying the spherical power to obtain the same spherical equivalent as the manifest refraction. This is done by subtracting half of the difference between topographic astigmatic power and the manifest astigmatic power from the spherical power (topography-modified treatment refraction).
- The standard postoperative treatment is combined steroids and antibiotics eye drops 5 times daily for one week ,then three times daily for three days and lubricant eye drops 5 times daily for six months.
Postoperatively, the patients will be examined at 1 week, 1 month and 3 months. All postoperative follow-up visits included measurement of UDVA, CDVA (if indicated) and refraction, besides full ophthalmological examination and performing pentacam and topolyzer after 3 months
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
- Double (Participant, Investigator)
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
- •Stable refractive error: Myopic astigmatism ≥ -1.5 D
- •Valid Topolyzer maps (at least four out of eight right maps with green analyzed area and the registration box is green).
排除标准
- •Estimated postoperative residual stromal bed thickness of less than 300µm.
- •Glaucomatous patients.
- •Patients with keratoconus.
- •Patients with pervious refractive surgery.
- •History of previous ocular trauma or surgery.
- •History of recent herpetic ulcer or viral keratitis.
- •Basement membrane disease, history of recurrent corneal erosions.
- •Sicca syndrome, dry eye.
研究组 & 干预措施
Group A: Manifest
20 eyes will be treated using Contoura, topography guided ablation vision with the standard manifest refraction.
干预措施: topography guided ablation (Procedure)
Group A: Manifest
20 eyes will be treated using Contoura, topography guided ablation vision with the standard manifest refraction.
干预措施: manifest refraction (Procedure)
Group B: partial TMR
20 eyes will be treated with Contoura vision, topography guided ablation using the topographic astigmatic power and axis and without change in the spherical power (using the same spherical power as the manifest refraction).
干预措施: topography guided ablation (Procedure)
Group B: partial TMR
20 eyes will be treated with Contoura vision, topography guided ablation using the topographic astigmatic power and axis and without change in the spherical power (using the same spherical power as the manifest refraction).
干预措施: partial topography modified refraction (Procedure)
Group C: Full TMR
20 eyes will be treated with Contoura vision, topography guided ablation using the topographic astigmatic power and axis and modifying the spherical power to obtain the same spherical equivalent as the manifest refraction. This is done by subtracting half of the difference between topographic astigmatic power and the manifest astigmatic power from the spherical power (topography-modified treatment refraction).
干预措施: topography guided ablation (Procedure)
Group C: Full TMR
20 eyes will be treated with Contoura vision, topography guided ablation using the topographic astigmatic power and axis and modifying the spherical power to obtain the same spherical equivalent as the manifest refraction. This is done by subtracting half of the difference between topographic astigmatic power and the manifest astigmatic power from the spherical power (topography-modified treatment refraction).
干预措施: full topography modified refraction (Procedure)
结局指标
主要结局
post operative residual astigmatism
时间窗: 3 months
measuring the post operative residual astigmatism and comparison between the 3 group to reach to the most accurate protocol.
次要结局
- measurement of the postoperative unaided visual acuity(3 months)
研究者
Fayrouz Aboalazayem
the principal investigator
Cairo University