A Randomised Controlled Trial Comparing the Outcomes of Different Irrigation-Aspiration Techniques for Viscoelastic Removal in Cataract Surgery
试验速览
- 阶段
- 1/2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 126
- 试验地点
- 1
- 主要终点
- Measurement of
研究概览
简要总结
Study Title
A Randomized Controlled Trial Comparing the Outcomes of Different Irrigation-Aspiration Techniques for Viscoelastic Removal in Cataract Surgery
Introduction
Ophthalmic viscoelastic devices (OVDs) are essential in cataract surgery to maintain anterior chamber depth, protect intraocular structures, and facilitate intraocular lens (IOL) implantation. Incomplete OVD removal, especially behind the IOL in the retrolental space, may cause postoperative complications like intraocular pressure (IOP) spikes, capsular block syndrome (CBS), and unintended refractive shifts.
Techniques Compared
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*Technique A:* Aspiration from the anterior chamber with IOL tapping.
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*Technique B:* Active aspiration behind the IOL using an irrigation and aspiration (IA) probe while maintaining capsular integrity.
Aim
To compare the efficiency and outcomes of these two IA techniques in OVD removal during phacoemulsification cataract surgery.
Study Design
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Prospective, double-blinded, randomized controlled trial.
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Total sample size: 126 patients (63 in each group).
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Single experienced surgeon performing all surgeries under standardized conditions.
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Follow-up at Day 1, Week 1, and Week 6 postoperatively.
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Outcomes measured: IOP, IOL position (anterior segment imaging), spherical equivalent refractive outcomes, anterior chamber depth changes.
Inclusion Criteria
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Age 50–80 years.
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Nuclear sclerosis grade II–III (LOCS III classification).
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Normal axial length 21.5–24.5 mm.
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No prior ocular surgery.
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Willingness to follow up.
Exclusion Criteria
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Glaucoma or ocular hypertension.
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Pseudoexfoliation syndrome or zonular instability.
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Corneal dystrophies or opacities.
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Poor pupil dilation <6 mm.
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History of uveitis or ocular trauma.
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Patients lost to follow-up.
Ethics
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Institutional ethical approval obtained.
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Adherence to Declaration of Helsinki.
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Informed consent obtained from all participants.
This trial aims to provide evidence-based guidance on the best irrigation-aspiration technique to reduce postoperative complications and improve visual outcomes after cataract surgery
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Double
入排标准
- 年龄范围
- 50.00 Year(s) 至 80.00 Year(s)(—)
- 性别
- All
入选标准
- •Nuclear sclerosis grade II—III (Lens Opacities Classification System III) Normal axial length (21.5—24.5 mm) No prior ocular surgery Follow up patients.
排除标准
- •Patients lost to follow-up Patients with Glaucoma, Corneal opacity, or dystrophy History of uveitis, trauma Pseudo-exfoliation or zonular instability Patients with poor pupil dilation -less than 6mm.
结局指标
主要结局
Measurement of
时间窗: Day 1, Week 1, Week 6
1.Intraocular pressure (IOP),
时间窗: Day 1, Week 1, Week 6
2 Intraocular Lens Position (IOLP) using anterior segment imaging.
时间窗: Day 1, Week 1, Week 6
3.Refractive outcomes-the spherical equivalent (SE)
时间窗: Day 1, Week 1, Week 6
4.Anterior chamber (AC) depth changes over the first 6 weeks post-surgery between the two groups.
时间窗: Day 1, Week 1, Week 6
次要结局
未报告次要终点
研究者
SUNKARA VENKATA MAHALAKSHMI
ALLURI SITARAMARAJU ACADEMY OF MEDICAL SCIENCES, ELURU
