| CTRI Number |
CTRI/2025/12/099192 [Registered on: 16/12/2025] Trial Registered Prospectively |
| Last Modified On: |
15/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
How common is dry eye disease after phacoemulsification cataract surgery |
|
Scientific Title of Study
|
Incidence of dry eye in a patient undergoing phacoemulsification cataract surgery |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Abu Saquib Afzal Haque |
| Designation |
Post Graduate Student Ophthalmology |
| Affiliation |
NETAJI SUBHAS MEDICAL COLLEGE AND HOSPITAL |
| Address |
Department of ophthalmology Netaji Subhas Medical College and Hospital Bihta Amhara Patna Bihar
Amhara Bihta Patna 801106 India
Patna
BIHAR
801106
India |
| Phone |
8884800786 |
| Fax |
|
| Email |
drsaquibafzal@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr ARJUN KUMAR SINGH |
| Designation |
Professor And Head of the Department Ophthalmology |
| Affiliation |
NETAJI SUBHAS MEDICAL COLLEGE AND HOSPITAL |
| Address |
HOD Department of ophthalmology Netaji Subhas Medical College and Hospital Bihta Amhara Patna Bihar
Amhara Bihta Patna 801106 India
Patna
BIHAR
801106
India |
| Phone |
8877884360 |
| Fax |
|
| Email |
drsaq@proton.me |
|
Details of Contact Person
Public Query
|
| Name |
Dr Abu Saquib Afzal Haque |
| Designation |
Post Graduate Student Ophthalmology |
| Affiliation |
NETAJI SUBHAS MEDICAL COLLEGE AND HOSPITAL |
| Address |
Department of ophthalmology Netaji Subhas Medical College and Hospital Bihta Amhara Patna Bihar
Amhara Bihta Patna Bihar 801106
Patna
BIHAR
801106
India |
| Phone |
8884800786 |
| Fax |
|
| Email |
drsaquibafzal@gmail.com |
|
|
Source of Monetary or Material Support
|
| NETAJI SUBHAS MEDICAL COLLEGE AND HOSPITAL Amhara Bihta Patna Bihar 801106 India |
|
|
Primary Sponsor
|
| Name |
Dr ABU SAQUIB AFZAL HAQUE |
| Address |
Department of ophthalmology Netaji Subhas medical college and hospital Amhara Bihta Patna |
| Type of Sponsor |
Other [SELF] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| ABU SAQUIB AFZAL HAQUE |
NETAJI SUBHAS MEDICAL COLLEGE AND HOSPITAL |
Department of Ophthalmology 1st floor Room no 108 Block A Amhara Bihta Patna
Patna
BIHAR |
8884800786
drsaquibafzal@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| NETAJI SUBHAS MEDICAL COLLEGE AND HOSPITAL |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H259||Unspecified age-related cataract, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
88.00 Year(s) |
| Gender |
Both |
| Details |
1) 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 |
|
| ExclusionCriteria |
| Details |
1. Patient having DED excluded in order to distinguish DED caused by Phacoemulsification cataract surgery from preexisting condition.
2. History of conditions affecting the surface of the eyes, such as allergic conjunctivitis, blepharitis, or pterygium.
3. Trauma to the operating eye or prior eye operations.
4. Systemic diseases such Sjogren syndrome, rheumatoid arthritis, or uncontrolled
diabetes mellitus that are known to impact tear production.
5. Patients those who wear contact lenses.
6. Use of systemic drugs such as Amiodarone, Busulfan, Steroid
7. A cataract that develops due to factors other than aging, such as trauma, uveitis, or medication side
effects
8. Glaucoma and patient having pre-existing ocular diseases such as
conjunctivitis, keratitis
9. Radiation and chemical burns.
10. Patient with previous ocular surgeries as SMILE, LASIK, KERATOPLASTY
11. Use of topical eye drugs particularly antihistamine within three months following surgery,
except for common postoperative drops like antibiotics and steroids |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare the health of the ocular surface and the stability of the tear film before and after
phacoemulsification surgery using metrics such as Schirmers test, TBUT, corneal staining,
within the time of 3 months |
Baseline, Post operative 1st week, 4th weeks, 12th weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the association of demographic elements for dry eye disease |
Baseline, Post operative 1st weeks, 4th weeks, 12th weeks |
|
|
Target Sample Size
|
Total Sample Size="94"
Sample Size from India="94"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
19/01/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
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
|