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临床试验/CTRI/2025/12/099192
CTRI/2025/12/099192尚未招募不适用

Incidence of dry eye in a patient undergoing phacoemulsification cataract surgery

Dr ABU SAQUIB AFZAL HAQUE1 个研究点 分布在 1 个国家目标入组 94 人开始时间: 2026年1月19日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
94
试验地点
1
主要终点
To compare the health of the ocular surface and the stability of the tear film before and after

研究概览

简要总结

Introduction:

Dry eye disease is a multifactorial disease of the ocular surface characterized by deficient tear production and/or excessive tear evaporation and the burden of Dry eye disease (DED) leads to discomfort in the eyes, fatigue, and blurred vision, which can negatively impact quality of life including physical, social, and emotional well-being, as well as daily

activities and work performance. Contributing factors include aging, female sex, autoimmune conditions, high blood pressure, diabetes, and wearing contact lenses. Certain medications, such as anticholinergics, antidepressants, oral contraceptives, and preservative-containing eye drops, are also known to induce dry eye symptoms. Pain relievers like aspirin and ibuprofen may worsen dry eye, as they are secreted into the tears, potentially increasing tear evaporation and disrupting tear film stability. Both systemic and topical ocular medications, as well as the preservatives in these drugs, can contribute to dry eye. These effects can result from the drug’s primary action, direct impacts on the additives or the ocular surface, and they could have a compounding effect. Phacoemulsification cataract surgery is a surgical technique to remove the nuclear portion of a cataracts lens using an aspirating and vibrating ultrasonic hand piece . It is the most fruitful and effective procedure, a widely used cataract surgery technique. There are certain complication and side effects such as endophthalmitis, conjunctival scarring, dysphotopsia and Dry eye disease (DED). Dry eye disease is one of the most common side effects . This can result from reduced corneal sensitivity due to surgical incisions, the use of antibiotic steroid  drops or ointments after surgery, postoperative inflammation, or exposure to bright surgical microscope light. Older age, gender, systemic diseases, certain drugs, mental health issues, meibomian gland dysfunction, preservatives in eye drops, surgical techniques, and patient lifestyle all risk factors for developing DED following phacoemulsification cataract surgery. Phacoemulsification cataract surgery is a risk factor for the induction and exacerbation of dry eye symptoms in up to one third of patients

研究设计

研究类型
Observational

入排标准

年龄范围
40.00 Year(s) 至 88.00 Year(s)(—)
性别
All

入选标准

  • Patients 40 years of age and older are undergoing phacoemulsification cataract surgery with intraocular lens implantation without any problems 2)willingness to cooperate with follow-up visits and give informed consent.
  • the capacity to comprehend and reply to surveys about dry eye symptoms.

排除标准

  • Patient having DED excluded in order to distinguish DED caused by Phacoemulsification cataract surgery from preexisting condition.
  • History of conditions affecting the surface of the eyes, such as allergic conjunctivitis, blepharitis, or pterygium.
  • Trauma to the operating eye or prior eye operations.
  • Systemic diseases such Sjogren syndrome, rheumatoid arthritis, or uncontrolled diabetes mellitus that are known to impact tear production.
  • Patients those who wear contact lenses.
  • Use of systemic drugs such as Amiodarone, Busulfan, Steroid
  • A cataract that develops due to factors other than aging, such as trauma, uveitis, or medication side effects
  • Glaucoma and patient having pre-existing ocular diseases such as conjunctivitis, keratitis
  • Radiation and chemical burns.
  • Patient with previous ocular surgeries as SMILE, LASIK, KERATOPLASTY
  • Use of topical eye drugs particularly antihistamine within three months following surgery, except for common postoperative drops like antibiotics and steroids.

结局指标

主要结局

To compare the health of the ocular surface and the stability of the tear film before and after

时间窗: Baseline, Post operative 1st week, 4th weeks, 12th weeks

phacoemulsification surgery using metrics such as Schirmers test, TBUT, corneal staining,

时间窗: Baseline, Post operative 1st week, 4th weeks, 12th weeks

within the time of 3 months

时间窗: Baseline, Post operative 1st week, 4th weeks, 12th weeks

次要结局

  • To assess the association of demographic elements for dry eye disease(Baseline, Post operative 1st weeks, 4th weeks, 12th weeks)

研究者

发起方
Dr ABU SAQUIB AFZAL HAQUE
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Abu Saquib Afzal Haque

NETAJI SUBHAS MEDICAL COLLEGE AND HOSPITAL

研究点 (1)

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