An observational and comparative study to evaluate correction of pre- existing astigmatism using paired opposite clear corneal incisions with and without limbal relaxing incisions in cataract patients undergoing topical phacoemulsification
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 96
- 试验地点
- 1
- 主要终点
- 1.To find out the impact of Paired Opposite Clear Corneal Incisions to correct preexisting astigmatism in cataract patients undergoing topical Phacoemulsification.
研究概览
简要总结
The purpose of this observational and comparative case study is to evaluate correction in pre- existing astigmatism six weeks after Phacoemulsification surgery with paired opposite clear corneal incisions with or without limbal relaxing incision. This study will make us understand the effectiveness of opposite clear corneal incision with limbal relaxing incision (For astigmastism of more than 1.50D) or without limbal relaxing incisions(For astigmatism of less than 1.50D) in correcting pre existing astigmatism. The study will also compare the routine phacoemulsification with temporal clear corneal incision to calculate surgically induced astigmatism. The site and extent of limbal relaxing incision will be based on Modified Gills Nomogram.
Patients who would have undergone topical Phacoemulsification surgery for cataract will be recruited. It will be a three group observational and comparative study including a control group. Keratometry will be done for the operated eye(s) free of charge to the patients. Comparative study will be done for various parameters as mentioned above and statistical analysis will be presented.
STUDY PROCEDURES :
This Observational comparative study will be conducted after approval from the Institutional Ethical Committee (IEC). Informed consent will be obtained from all the patients enrolled after phacoemulsification surgery.
The study patients will be divided into 3 groups based on the astigmatism correcting incisions given during phacoemulsification :-
Group 1 : In this group patients with astigmatism of less than or equal to 1.25 D will be recruited. These patients would have already been given Paired Opposite Clear Corneal incisions on the steeper axis (without Limbal Relaxing Incisions) during their Phacoemulsification cataract surgery.
Group 2 : In this group patients with astigmatism of more than 1.25 D will be recruited. These patients would have already been given Paired Opposite Clear Corneal incisions on the steeper axis along with Limbal Relaxing Incisions (as per modified Gill’s nomogram) during their Phacoemulsification cataract surgery.
Group 3 : Control Group - This group will include patients who would have undergone routine Phacoemulsification with clear corneal incisions on the steeper axis without any additional corneal incisions (to calculate surgically induced astigmatism).
Patients will be recruited based on the criteria of each group. The patients will be recruited in the OPD during their routine post-operative visits to the operating surgeon. There will be intra group comparison of astigmatism as well as inter group comparison.
All the patients from each group will undergo basic ophthalmic evaluation including but not limited to automated refraction, automated keratometry, uncorrected and best corrected visual acuity testing, measurement of intraocular pressure by non-contact tonometer, slit lamp examination of anterior segment and the retina after the surgery.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 30.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •1.All patients visiting OPD who have undergone topical clear corneal phacoemulsification cataract surgery.
- •2.All genders with age group between 30 yrs to 80 yrs.
排除标准
- •Evidence of corneal trauma on biomicroscopic examination.
- •Evidence of acute or chronic corneal infections ,corneal ectasia.
- •Corneal dystrophies and Corneal degenerations.
- •Inflammatory conditions of the cornea or conjunctiva.
- •Patients with Pterygium.
- •Previous ocular surgeries.
- •Patients developing hypertrophic scars or nodules during wound healing.
- •Any intraoperative complications related to the main corneal incisions e.g. premature entry, wound burn, wound extension etc will be excluded from this study.
结局指标
主要结局
1.To find out the impact of Paired Opposite Clear Corneal Incisions to correct preexisting astigmatism in cataract patients undergoing topical Phacoemulsification.
时间窗: 6 weeks
2.To find out the impact of Paired Opposite Clear Corneal Incisions combined with Limbal Relaxing Incisions to correct preexisting astigmatism in cataract patients undergoing topical Phacoemulsification.
时间窗: 6 weeks
3.To find out the stability of the correction achieved six weeks after the Phacoemulsification surgery.
时间窗: 6 weeks
次要结局
- 1. To compare the amount of astigmatism corrected between the above two groups of patients with opposite clear corneal incisions.(2. To find out surgically induced astigmatism (SIA) in a third group with incision on the steeper axis and without opposite clear corneal incisions (Control Group).)
研究者
Dr Priyanka Maurya
Bhaktivedanta Hospital and Research Institute