ISRCTN14033075已完成未知
Direct selective laser trabeculoplasty (DSLT) in open angle glaucoma (OAG): a randomized controlled trial
BELKIN Laser Ltd0 个研究点目标入组 276 人开始时间: 2017年3月27日最近更新:
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 276
研究概览
简要总结
2021 Protocol article in https://pubmed.ncbi.nlm.nih.gov/34433548/ protocol (added 27/08/2021)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Age 40 years or older, with visual acuity > 6/60 in both eyes
- •2. Primary open-angle glaucoma including exfoliative or pigmentary glaucoma; added 03/06/2020: or ocular hypertension
- •3. IOP = 22mmHg to =35mmHg (in the case of a medicated patient at the baseline visit following washout and in the case of a naïve (newly diagnosed) patient at the time of screening)
- •4. Gonioscopically visible scleral spur for 360 degrees without indentation
- •5. Ability to visualize the peri-limbal sclera for 360 degrees (using a speculum)
- •6. Willing and able to participate in the 12-month study, to comply with the study procedures and to adhere to the follow-up schedule
- •7. Participant capable of giving informed consent
排除标准
- •Individuals with the following characteristics will be excluded from the study (unless specified otherwise, all ocular criteria refer to the study eye only):
- •1. Contraindications to conventional laser trabeculoplasty (e.g. corneal abnormalities, etc)
- •2. Angle Closure Glaucoma
- •3. Congenital or developmental glaucoma
- •4. Secondary glaucoma except exfoliative or pigmentary glaucoma
- •5. Presence of any Peripheral Anterior Synechiae (PAS) in the study eye
- •6. Inability to conduct a reliable visual field (defined as fixation losses, false positives or false negatives greater than 33%)
- •7. Any of the following visual field findings using the Humphrey visual field analyzer the SITA-standard 24-2 program:
- •7.1. A visual field MD of less than -12dB
- •7.2. Greater than or equal to 75% of points depressed below the 5% level and greater than or equal to 50% of points depressed below the 1% level on the PD plot
- •7.3. At least 50% of points (i.e., 2 or more) within the central 5 degrees with a sensitivity =0dB on the decibel plot
- •7.4. Points within the central 5 degrees of fixation with a sensitivity <15 dB in both hemifields on the decibel plot
- •8. A visual field MD of less than -12dB in the fellow eye
- •9. Cup:Disc Ratio of more than 0.8
- •10. More than two hypotensive mediations required
- •11. Prior incisional or laser glaucoma surgery
- •12. Prior corneal refractive surgery
- •13. Complicated cataract surgery = 6 months prior to enrollment
- •14. Presence of visually significant cataract in the opinion of the investigator
- •15. Clinically significant disease in either eye as determined by the Investigator
- •16. Clinically significant amblyopia in either eye
- •17. Women who are pregnant or may become pregnant during the course of the study
- •18. Added 16/03/2018: Dense pigmentation or haemorrhage in the peri-limbal conjunctiva or anterior sclera
- •19. In the opinion of the investigator the participant might require other ocular surgery within the 12-month follow-up period, unless for further reduction of their IOP
- •20. Concurrent treatment with topical, nasal, inhaled or systemic steroids
- •21. Uncontrolled systemic disease that could impact the ability of the participant to attend follow up visits as per the discretion of the investigator
研究者
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