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临床试验/NCT03844178
NCT03844178Unknown2 期

Role of Pupil Centroid Shift Compensation on Lower and Higher Order Aberrations During Photorefractive Keratectomy: An Eye-to-Eye Study

Shahid Beheshti University of Medical Sciences1 个研究点 分布在 1 个国家目标入组 104 人开始时间: 2019年2月10日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
入组人数
104
试验地点
1
主要终点
Postoperative refractive error

研究概览

简要总结

patients who are candidates of PRK will be recruited in this intrasubject randomized clinical trial. Inclusion criteria are myopia or myopic astigmatism with refractive cylinder. Exclusion criteria were unstable refractive error, age less than 21 years old, corneal opacity, keratoconus, keratoconus suspects, residual corneal stromal thickness less than 350 µm, moderate or severe dry eye disease and any other ocular pathology other than refractive error. Complete eye exam will be performed preoperatively including: uncorrected distance visual acuity (UDVA), best spectacle corrected distance visual acuity (CDVA), cyclorefraction, slit lamp biomicroscopy, Goldmann applannation tonometry, dual scheimpflug tomography (Ziemmer), topography in mesopic condition accompanied by pupilometry and iris registration (Topolyzer Vario, Alcon Laboratories, Inc., Fort Worth, TX), and funduscopy with dilated pupil.

Surgical Technique The same surgeon (A.F.) will perform all surgeries. After installation of Tetracaine 1%, periorbital skin will be prepared with povidone iodine 5%. Iris registration will be performed in all eyes before epithelial removal. Ethylalcohol 20.0% into a 9.0 mm well for 20 seconds will be applied on the central cornea, and then the epithelium of the central 9.0 mm area will be removed by hockey knife. In the right eye of each patient PCS compensation will be turned on (PCS-On group) and in the left eye it will be turned off (PCS-Off group). Excimer laser ablation will be performed by Wavelight Allegretto EX500 (Alcon, Fort Worth, TX, USA). Selection of which eye to be first ablated will be done randomly. Randomization will be performed based on a computer software by a Biostatistician which produced the first eye to be operated. Static cyclotorsion compensation will be active in all eyes. The ablation profile will be wavefront-optimized in all cases.

Postoperative Course Postoperatively, chloramphenicol 0.5% eye drops and betamethasone 0.1% eye drops will be prescribed every 6 hours for 10 days. Thereafter, Fluorometholone 0.1% eye drops every 6 hours for 1 month and every 8 hours for the next month will be given. Follow-up examinations were scheduled at 1, 2, 3, 4, 7 and 15 days and 1, 2, 3, and 6 months postoperatively. After contact lens removal each follow-up examination includes the UDVA, manifest refraction, and IOP measurements as well as a slit lamp biomicroscopy. Corneal imaging with Galilei tomography, CDVA and cyclorefraction will be performed at the final follow-up examination 6 months postoperatively.

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
Single (Participant)

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • myopic astigmatism

排除标准

  • unstable refractive error, age less than 21 years old
  • corneal opacity
  • keratoconus, keratoconus suspects
  • residual corneal stromal thickness less than 350 µm
  • moderate or severe dry eye disease
  • any other ocular pathology other than refractive error

研究组 & 干预措施

The right eyes with compensation for Pupil centroid shift

Active Comparator

干预措施: The option for compensation of Pupil centroid shift was ON (Procedure)

The right eyes with compensation for Pupil centroid shift

Active Comparator

干预措施: installation of Tetracaine 1% (Drug)

The right eyes with compensation for Pupil centroid shift

Active Comparator

干预措施: Photorefractive keratectomy (PRK) (Procedure)

The left eyes without compensation for Pupil centroid shift

Active Comparator

干预措施: The option for compensation of Pupil centroid shift was OFF (Procedure)

The left eyes without compensation for Pupil centroid shift

Active Comparator

干预措施: installation of Tetracaine 1% (Drug)

The left eyes without compensation for Pupil centroid shift

Active Comparator

干预措施: Photorefractive keratectomy (PRK) (Procedure)

结局指标

主要结局

Postoperative refractive error

时间窗: 2 months

Snellen chart and subjective refraction

次要结局

  • Root Mean Square (RMS) of higher order aberration(6 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Zahra Rabbani Khah

Head of ophthalmic research center

Shahid Beheshti University of Medical Sciences

研究点 (1)

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