| CTRI Number |
CTRI/2021/08/035502 [Registered on: 06/08/2021] Trial Registered Prospectively |
| Last Modified On: |
05/08/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Comparing occurrence of dry eye following cataract surgery by phacoemulsification and MSICS |
|
Scientific Title of Study
|
Comparison of clinical and inflammatory markers for dry eye disease following phacoemulsification and manual small incision cataract surgery |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Hemanth R |
| Designation |
Junior resident |
| Affiliation |
JIPMER, Puducherry |
| Address |
Department of Ophthalmology
Jawaharlal Institute of Post-Graduate Medical Education and Research (JIPMER)
Dhanvantri Nagar
Puducherry
Pondicherry
PONDICHERRY
605006
India |
| Phone |
7975342007 |
| Fax |
|
| Email |
hemanthramachandar15@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Geeta Behera |
| Designation |
Assistant Professor |
| Affiliation |
JIPMER, Puducherry |
| Address |
Department of Ophthalmology
Jawaharlal Institute of Post-Graduate Medical Education and Research (JIPMER)
Dhanvantri Nagar
Puducherry
Pondicherry
PONDICHERRY
605006
India |
| Phone |
04132296291 |
| Fax |
|
| Email |
geeta.anandaraja@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Geeta Behera |
| Designation |
Assistant Professor |
| Affiliation |
JIPMER, Puducherry |
| Address |
Department of Ophthalmology
Jawaharlal Institute of Post-Graduate Medical Education and Research (JIPMER)
Dhanvantri Nagar
Puducherry
Pondicherry
PONDICHERRY
605006
India |
| Phone |
04132296291 |
| Fax |
|
| Email |
geeta.anandaraja@gmail.com |
|
|
Source of Monetary or Material Support
|
| Jawaharlal Institute of Post-Graduate Medical Education and Research (JIPMER) Intramural Research Fund (IMRF) |
|
|
Primary Sponsor
|
| Name |
JIPMER |
| Address |
Jawaharlal Institute of Post-Graduate Medical Education and Research (JIPMER)
Dhanvantri Nagar
Puducherry
605006 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Geeta Behera |
Jawaharlal Institute of Post-Graduate Medical Education and Research (JIPMER) |
Department of Ophthalmology (OPD and Ward), Department of Biochemistry, Department of Pathology
Pondicherry
PONDICHERRY |
04132296291
geeta.anandaraja@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| JIPMER Institutional Ethics Committee (JIEC) |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H259||Unspecified age-related cataract, |
|
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Intervention / Comparator Agent
|
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Inclusion Criteria
|
| Age From |
41.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Inclusion criteria:
Patients with senile cataract above the age of 40 years undergoing cataract surgery by MSICS or phacoemulsification
|
|
| ExclusionCriteria |
| Details |
Exclusion criteria:
1.Patients developing intra-operative or post- operative complications.
2.Glaucoma patients undergoing cataract surgery on prior topical anti-glaucoma medications.
3.Patients using any topical medications on a long-term basis for other ocular conditions like glaucoma, uveitis, etc.
4.Patients with lid abnormalities (entropion, ectropion, trichiasis) or exposure changes due to thyroid eye disease or facial nerve palsy.
|
|
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Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Among patients undergoing cataract surgery by manual small incision cataract surgery and phacoemulsification:
i. To compare ocular symptom scores, Schirmer’s I values, TBUT values and corneal surface staining score pre-operatively and post-op day 1, 3 weeks and 2 months
ii. To compare tear film inflammatory markers (IL-1β, IL-6) and meibomian gland changes pre-operatively and post-op day 1, 3 weeks and 2 months
iii. To compare impression cytology score pre-op, 3 weeks and 2 months. |
pre-operatively and post-op day 1, 3 weeks and 2 months |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
| To study the effect of age, gender and occupation on Schirmer’s I values, TBUT values, corneal surface staining score, impression cytology score, tear film inflammatory markers (IL-1β, IL-6) and meibomian gland changes in these patients |
pre-operatively and post-op day 1, 3 weeks and 2 months |
|
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Target Sample Size
|
Total Sample Size="86"
Sample Size from India="86"
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)
|
15/08/2021 |
| 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="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
|
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
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Brief Summary
|
Dry eye disease(DED) is currently defined as a multifactorial disease of the ocular surface characterized by a loss of homeostasis of the tear film and accompanied by ocular symptoms in which tear film instability and hyperosmolarity, ocular surface inflammation and neurosensory abnormalities play etiological roles. The new DED definition puts more emphasis on the homeostasis of the tear film and diagnostic homeostasis marker tests. A recommended work up for DED includes screening with a questionnaire and homeostasis markers (non-invasive tear break-up time, osmolarity and staining) in which case DED is diagnosed if the patient has symptoms and one of the homeostasis markers is positive even without the full battery of recommended tests. Cataract surgery has been shown to be responsible for transiently inducing or exacerbating dry eye; studies have shown uncomplicated phacoemulsification can increase dry eye symptoms but generally the symptoms resolve after about 3 months. The signs associated with post-cataract dry eye include decrease in tear break up time, increase ocular surface staining and changes in tear volume. There have been a few studies from India demonstrating the pattern of dry eye after cataract surgery. MSICS is one of the most commonly performed cataract surgeries in our country and is gradually being adopted worldwide. This study will help us know the incidence of DED after MSICS and phacoemulsification and if there a difference depending on surgical technique used viz. MSICS versus phacoemulsification. By calculating the incidence and pattern of dry eye after cataract surgery, we could develop new therapeutic strategies to reduce and treat post-operative dry eye more effectively.
Hypothesis: Patients undergoing cataract surgery by MSICS have greater occurrence and extent of dry eye disease as compared to phacoemulsification. |