CTRI/2010/091/000685招募中未知
Clinical investigation of the femtosecond laser system for the refractive correction of hyperopic eyes by means of lenticule extraction.
Mr. Samir ShahNew Vision Laser Centers (Rajkot) Pvt. Ltd. 203, Embassy Building, Jawahar Road, Opp. Jubilee Baug, Rajkot 360 001.Gujarat, India. Ph: (0281) 2240241, 2240239 Fax: (0281) 22402390 个研究点目标入组 100 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 发起方
- 入组人数
- 100
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •Older than 21
- •Central corneal thickness > 500 urn and calculated residual stroma thickness > 250 urn
- •Normal cornea topography
- •No prior refractive surgery
- •The patients commit themselves to taking part in the post-surgery examinations planned for
- •the clinical investigation.
- •Patients who wear contact lenses should stop wearing their lenses 4 weeks before the
- •preliminary examination in the case of hard lenses and 2 weeks before in the case of soft
- •Patients should exhibit one of the following vision defects:
- •a)Subjective hyperopia (SPH) of up to +8 D of natural cause, measured at the cornea level
- •b)Subjective astigmatism (CYL) of up to 5 D, natural cause
- •c)Spherocylindrical combinations of up to +8 D SEQ
- •There are no restrictions regarding gender or race.
- •The patients must sign a patient consent declaration which explains the conditions under
- •which they take part in the clinical investigation, the alternative treatment types and the risks.
排除标准
- •Patients who cannot lie flat and still for a short period
- •Patients who are not capable of making themselves understood or giving their consent
- •Known allergies or intolerances to medications administered
- •Immunosuppressed patients, e.g. patients with AIDS or autoimmune disorders
- •Treatment with medication which influence wound healing, e.g. steroids, antimetabolites and
- •immunosuppressors
- •Diagnosis of diabetes or connective tissue disorders
- •Pregnant and breastfeeding women, plus women who are planning a pregnancy in the period
- •of the clinical study
- •Unstable refraction
- •Any residual, recurrent, or acute ocular disease or abnormality of the eye to be treated.
- •Cataract Suspected glaucoma or intraocular pressure >21mm Hg
- •Disease of the cornea Disease involving thinning of the cornea such as keratoconus and
- •pellucid marginal degeneration
- •Dystrophy of basement membrane
- •Exudative macular degeneration
- •Infections and inflammations of the eye, e.g. uveitis, iritis, blepharitis
- •Existing, recurrent, or acute ocular disease or abnormality of the eye to be treated.
- •Existing corneal implant
- •Lesion or scarring of the cornea
- •Herpes simplex or herpes zoster keratitis
- •Participation in other ophthalmic studies
研究者
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