CTRI/2017/12/010759已完成未知
Prospective intracameral moxifloxacin endothelial safety study in patients having cataract surgery comparing 500 mcg/0.1 ml in one eye and 250 mcg/0.1ml in the opposite eye
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 25
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
- •Subjects MUST:
- •1.Provide signed and dated written informed consent.
- •2.Be 45 - 85 years of age
- •3.Have bilateral cataracts with similar nuclear density in each eye, and which is less than NO4/NC4 on the Lens Opacities Classification System III (LOCSIII) eligible for cataract extraction.
- •4.Be suitable for the surgeonââ?¬•s standard phacoemulsification technique.
- •5.Be able and willing to follow study instructions and complete all required visits
- •6.At Eligibility (Visit 2/Day -7), have ECD of >2000 cells/mm2 in both eyes with difference between eyes being <200 cells as assessed by a centralized reading center.
排除标准
- •Subjects MUST NOT:
- •1.Have any ocular disease other than cataract (uncontrolled glaucoma, blunt or penetrating ocular trauma, uveitis, endothelial corneal dystrophy)
- •2.Have pseudoexfoliation, or small pupils that would require expansion devices
- •3.Taking immunosupressants, systemic alpha blockers, or anticoagulants
- •4.Have bilateral nuclear density NO4/NC4 on the Lens Opacities Classification System III (LOCSIII) or greater.
- •5.Previous angle closure glaucoma or shallow anterior chambers.
- •6.Previous hard (PMMA) contact lens wear.
- •7.Have uncontrolled systemic disease (e.g. diabetes)
- •8.Current or history of severe hepatic or renal impairment. Have severe cardiovascular disease unless his/her disease is controlled and clearance has been obtained from the treating primary care physician or cardiologist
- •9.If female of childbearing potential - Be pregnant, nursing, or planning a pregnancy during study entry and through the duration of the study.
- •10. Have clinically relevant, abnormally low or high blood pressure or pulse rate (normal ranges: systolic: 90-160 mm Hg; diastolic: 55-90 mm Hg; pulse rate: 50-100 bpm)
- •11.Use of intracameral pilocarpine or adrenaline during the surgery
- •12.Have any known allergy or sensitivity to the study medications or their components (moxifloxacin).
- •13.Require the use of any ocular medications during the study other than the study medications; occasional use of artificial tears for mild dry eye or lid scrubs for mild blepharitis is allowed. [Note: If subject uses artificial tears or lib scrubs, the treatment must be administered at least 30 minutes prior to study medication instillation].
- •14.Have any contraindications to moxifloxacin
- •15.Have any active ocular disease other than glaucoma that requires treatment or may affect the safety or efficacy of the study medication, in the opinion of the investigator. Please note, artificial tears for mild dry eye and lid scrubs for mild blepharitis are allowed.
- •16.Have any opacity or subject uncooperativeness that restricts adequate examination of the anterior chamber
- •17.Current or history within 2 months prior to eligibility visit infectious/non-infectious ocular disease or condition conjunctivitis, keratitis, or uveitis in any eye. However, subjects with cataract, age-related macular degeneration or diabetic retinopathy can be enrolled as per discretion of investigator.
- •18.Have refractivesurgery,lasertrabeculoplasty,orotherlasersurgerywithinthepast 3months,orotherocular surgery (e.g. filtering surgery)withinthepast12months
- •19.Be enrolled in an investigational drug or device study or have participated in such a study within 30 days prior to eligibility visit.
研究者
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