RBR-65rzrv招募中未知
A Prospective randomized multicenter study comparing Transscleral Cyclophotocoagulation and Trabeculectomy as a Primary Surgical Procedure in Glaucoma
Centro de Referência em Oftalmologia da Universidade Federal de Goiás (CEROF-UFG)0 个研究点开始时间: 2020年6月24日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Intervention
入排标准
- 年龄范围
- 18Y 至 90Y（—）
入选标准
- •The study will include patients aged over 18 years with the following glaucoma subtypes: POAG, pigmentary glaucoma (PG), pseudo-exfoliation glaucoma (PEX), and cortisone glaucoma. The patients must have glaucoma refractory to clinical treatment and not in the target IOP, defined by the physician responsible for the case or with VF progression (22) confirmed with the current IOP.
- •All patients must have at least one reliable SITA Standard 24-2 VF exam (Humphrey Systems, Dublin, CA, USA) and with characteristic glaucoma changes according to the criteria proposed by Hodapp-Parrish-Anderson (HPA) (23), OD examination showing typical glaucoma lesion, i.e., neural rim focal thinning or global loss, vascular changes, and/or localized RNFL defects (24), and the ability to perform VF testing in at least one eye.
- •Pseudo-phakic patients must have a history of a previous cataract surgery using the phacoemulsification technique (PHACO ) with a corneal incision without stitches and intraocular lens (IOL) implantation within a capsular bag and without complications described in the patient’s medical chart and/or confirmed with detailed examination of the eye in mydriasis.
排除标准
- •Exclusion criteria will be as follows: absence of light perception vision; loss or deficit of vision in any eye of unknown cause or other than glaucoma; unreliable VF; aphakia or any other changes at biomicroscopy or ophthalmoscopy that may affect VF examination, such as age-related macular degeneration (AMD) or retinal detachment (RD); or recent participation in another research protocol (six months). VF will only be an inclusion criterion for patients with corrected VA better than 20/200. Patients below this level will not undergo the VF exam to be included in the study.
- •Pregnant or lactating patients will be excluded from the study. Patients with a history of any other intraocular surgery (except cataracts, as previously described); previous anti-glaucoma surgery (any technique); need for other surgeries concomitant with glaucoma surgery, such as for cataracts; aphakia; history of cataracts with complications, such as posterior capsule rupture, vitreous loss, or IOL implantation in the groove; conjunctival scars that may prevent or hinder TREC, such as sequelae from burns or pterygium surgery; corneal scars that may hinder the IOP measurement; or history or evidence of uveitis (active or not) will also be excluded.
- •Patients with ocular hypertension, normal pressure glaucoma (NPG), PCAG, neovascular glaucoma (even treated), congenital or juvenile glaucoma, endothelial iridocorneal syndrome, traumatic glaucoma, secondary glaucoma, or any conditions that, at medical discretion, will contraindicate any of the techniques proposed in the study will also be excluded.
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