| CTRI Number |
CTRI/2024/05/067575 [Registered on: 17/05/2024] Trial Registered Prospectively |
| Last Modified On: |
16/05/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Punctal Cautery in Dry Eye Syndrome |
|
Scientific Title of Study
|
Randomized Controlled Study on the Efficacy of Punctal Cautery in severe Dry Eye disease |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrSwati Singh |
| Designation |
Ophthalmologist |
| Affiliation |
L V Prasad Eye Institute |
| Address |
L V Prasad Eye Institute, room No:123, Clinical Research Department, GPR building,
Banjara Hills, Road No:02
Hyderabad
Hyderabad
TELANGANA
500034
India |
| Phone |
7036981646 |
| Fax |
|
| Email |
swatisingh@lvpei.org |
|
Details of Contact Person
Scientific Query
|
| Name |
DrSwati Singh |
| Designation |
Ophthalmologist |
| Affiliation |
L V Prasad Eye Institute |
| Address |
L V Prasad Eye Institute, Room No: 123, Clinical Research Department, 1st floor, GPR building,Banjara Hills, Road No:02,Hyderabad
Hyderabad
TELANGANA
500034
India |
| Phone |
7036981646 |
| Fax |
|
| Email |
swatisingh@lvpei.org |
|
Details of Contact Person
Public Query
|
| Name |
DrSwati Singh |
| Designation |
Ophthalmologist |
| Affiliation |
L V Prasad Eye Institute |
| Address |
L V Prasad Eye Institute, Room No: 123, Clinical Research Department, 1st floor, GPR building,Banjara Hills, Road No:02,Hyderabad
Hyderabad
TELANGANA
500034
India |
| Phone |
7036981646 |
| Fax |
|
| Email |
swatisingh@lvpei.org |
|
|
Source of Monetary or Material Support
|
| L V Prasad Eye Institute, Room No: 123, Clinical Research Department, 1st floor, GPR building,Banjara Hills, Road No:02,Hyderabad 500034, Telangana, India |
|
|
Primary Sponsor
|
| Name |
L V Prasad Eye Institute |
| Address |
L V Prasad Eye Institute, Room No: 123, Clinical Research Department, 1st floor, GPR building,Banjara Hills, Road No:02,Hyderabad 500034, Telangana, India |
| Type of Sponsor |
Other [Not for profit] |
|
|
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 |
| DrSwati Singh |
L V Prasad Eye Institute |
L V Prasad Eye Institute, Room No: 123, Clinical Research Department, 1st floor, GPR building,Banjara Hills, Road No:02,Hyderabad 500034,Telangana, India
Hyderabad
TELANGANA |
7036981646
swatisingh@lvpei.org |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee, L V Prasad Eye Institute |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, (2) ICD-10 Condition: H578||Other specified disorders of eye and adnexa, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Punctal cautery |
Participants in this group will undergo punctal cautery of the puncta bilaterally.
1 month and 3 month follow up. |
| Comparator Agent |
Sham procedure |
Participants in this group will receive standard treatment for DED (Artificial tears, cyclosporine), following the institutions standard of care.
1 month and 3 months follow up. |
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Aged 5–70 years
2. Have OSDI scores ≥33 or Oxford staining grade ≥2
3. Diagnosis of DED in both eyes supported by the criteria mentioned below
a.A symptom severity score of ≥33 for OSDI
b.An unanesthetized Schirmer Tear Test (STT) score of ≥1 mm and ≤5 mm per 5 minutes
c.Evidence of ocular surface staining (total fluorescein staining score of at least 3) [0-15 scale])
4. Have normal lid anatomy and diagnosed with severe dry eye (ATDDE)
5. DED refractory to medical management
|
|
| ExclusionCriteria |
| Details |
1.History of punctal occlusion or punctal dilation.
2.Active ocular infection or inflammation.
3.Use of punctal plugs within the past 3 months.
4.Pregnancy or lactation women.
5.Any systemic or ocular condition that may interfere with the study assessments or participant safety.
6.Punctal plug or contact lenses.
7.Ocular surgery within 6 months.
Have no contraindication for blood donation
8.Positive HIV, hepatitis B or C, or syphilis.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in dry eye symptoms assessed using validated questionnaires such as the Ocular Surface Disease Index (OSDI) score. |
1 month, 3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Visual Acuity, Adverse events related to intervention |
1 month and 3 months |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
30/05/2024 |
| 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="1"
Days="1" |
|
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
|
Dry eye syndrome (DES) is a prevalent ocular condition characterized by a disruption in tear film stability and ocular surface inflammation, leading to symptoms such as ocular discomfort, visual disturbances, and, in severe cases, corneal damage. Punctal cautery, a minimally invasive procedure involving the thermal occlusion of puncta, has been suggested as a potential therapeutic option for dry eye disease (DED). However, evidence on its efficacy and safety is limited, necessitating a randomized controlled trial to evaluate its utility in managing DES. |