CTRI/2021/11/037924招募中未知
Prospective evaluation of the clinical safety and effectiveness of hydrophilic acrylic intraocular lens. - UVEA 809
试验速览
- 阶段
- 未知
- 状态
- 招募中
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
入选标准
- •1. Patients of any gender, aged 18 years or older
- •2. Patient is planned for aged-related cataract surgery and implantation of the
- •study IOL into the capsular bag in at least one eye
- •3. Patient is willing and capable of providing informed consent
- •4. Patient is willing and capable of complying with visits and procedures as
- •defined by this protocol
排除标准
- •1. Preoperative corrected distance visual acuity (CDVA) better than 0.3
- •logMAR (0.5 decimal)
- •2. Endothelial cell count of less than 2000/mm2
- •3. Ocular disorder that could potentially cause a clinically significant future
- •visual acuity loss
- •4. Preoperative corneal astigmatism ââ?°Â¥ 1 D or preoperative corneal
- •astigmatism ââ?°Â¥ 1.5 D, if postoperative corneal astigmatism is not estimated
- •to be < 1 D.
- •5. Clinically significant anterior segment pathology (e.g. chronic uveitis, iritis,
- •aniridia, rubeosis iridis, anterior membrane dystrophies, poor pupil dilation,
- •6. Clinically significant abnormal corneal finding (e.g. keratoconus, pellucid
- •marginal degeneration, or irregular astigmatism, clinically significant
- •corneal membrane dystrophies)
- •7. Any clinically significant condition that could affect IOL stability (e.g.
- •zonular dialysis, evident zonular weakness or dehiscence, etc.)
- •8. Any History of clinically significant retinal pathologies or ocular diagnosis
- •(e.g. diabetic retinopathy, ischemic diseases, macular degeneration, retinal
- •detachment, optic neuropathy optic nerve atrophy, amblyopia, strabismus,
- •microphthalmos, aniridia, epiretinal membrane etc.) that could alter or limit
- •final postoperative visual prognosis
- •9. Any acute infection (acute ocular disease, external/internal infection,
- •systemic infection)
- •10. Any previous intraocular and corneal surgery
- •11. Uncontrolled glaucoma or IOP higher than 24mmHg under ocular
- •hypertension treatment
- •12. Current systemic or ocular pharmacotherapy that effects patientsââ?¬• vision
- •13. Current pathology or condition that could be a risk for the patient according
- •to the investigator opinion
- •14. Women during pregnancy and/or lactation
- •15. Patients unable to meet the limitations of the protocol or likely of noncooperation
- •during the trial
- •16. Patients whose freedom is impaired by administrative or legal order
- •17. Subject is enrolled in any other concurrent clinical study, with the exception
- •of local mandatory governmental registries and observational
- •studies/registries, that do not affect patientsââ?¬• vision
- •Note All eye-related inclusion and exclusion criteria are applicable to the study eye only.
- •If the non-study eye does not fulfil all criteria, the patient can still be enrolled into
研究者
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