| CTRI Number |
CTRI/2026/01/100300 [Registered on: 05/01/2026] Trial Registered Prospectively |
| Last Modified On: |
03/01/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Biological |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Role of simultaneous use of patients own serum along with antifungal medicines in fungal corneal ulcer healing
|
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Scientific Title of Study
|
Role of Adjuvant Autologous Serum in Fungal Corneal Ulcer Healing:
A Randomized Controlled Trial |
| 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 Indu Bala |
| Designation |
Senior resident |
| Affiliation |
Advanced Eye Centre, Department Of Ophthalmology, PGIMER, Chandigarh |
| Address |
Advanced Eye Centre, Department Of Ophthalmology, Post graduate Institute of Medical Education and Research,Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
8628817195 |
| Fax |
|
| Email |
drindudhiman@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Parul Chawla Gupta |
| Designation |
Additional Professor |
| Affiliation |
Advanced Eye Centre, Department Of Ophthalmology, PGIMER, Chandigarh |
| Address |
Advanced Eye Centre, Department Of Ophthalmology, Post graduate Institute of Medical Education and Research,Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9876764629 |
| Fax |
|
| Email |
pcgpgi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Indu Bala |
| Designation |
Senior resident |
| Affiliation |
Advanced Eye Centre, Department Of Ophthalmology, PGIMER, Chandigarh |
| Address |
Advanced Eye Centre, Department Of Ophthalmology, Post graduate Institute of Medical Education and Research,Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
8628817195 |
| Fax |
|
| Email |
drindudhiman@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Ophthalmology, Advanced Eye Centre,Postgraduate Institute of Medical Education and Research ,Chandigarh, India, Pin code 160012 |
|
|
Primary Sponsor
|
| Name |
PGIMER Chandigarh |
| Address |
Department of Ophthalmology, Advanced Eye Centre,Postgraduate Institute of Medical Education and Research ,Chandigarh, India, Pin code 160012 Edit || Delete
|
| 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 Indu Bala |
Postgraduate Institute of Medical Education and Research, Chandigarh |
Room no.116,Office,Department of Ophthalmology,Advanced Eye Centre, PGIMER, Chandigarh
Chandigarh
CHANDIGARH |
8628817195
drindudhiman@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Postgraduate Institute of Medical and Research, Chandigarh, Institutional Ethics Committee( Intramural) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H160||Corneal ulcer, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Use of 50 %Autologous serum eye drops |
Autologus serum will be prepared in Microbiology lab of Advanced Eye Center. “Approximately 10 ml blood will be collected in plain vacutainer tubes without anticoagulant and allowed to clot for 30–45 minutes at room temperature. This will then be centrifuged at 2500–3000 rpm for 5 minutes and the supernatant amber color fluid is serum.Equal amount of sterile tear substitute (carboxymethylcellulose 0.5%, containing purite as preservative) will be added to the serum for dilution.. Autologus serum will be stored in refrigerator at 4 degree celcius and for transportation frozen gel packs will be used.Eye drops will be used 6 times a day until epithelisation. After every one week, fresh autologous serum eye drops will be prepared. Eye drops will be used 6 times a day until epithelisation.
|
| Comparator Agent |
There will be two groups in the study. |
Group A will receive standard antifungal treatment and Group B will receive autologous serum eye drops in addition to standard of care. |
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
KOH stain positive corneal ulcers,Mild to moderate in severity will be included in the study
|
|
| ExclusionCriteria |
| Details |
Bacterial and mixed corneal ulcers,Ulcers warranting immediate surgical intervention (impending perforation/ perforated ulcer)Endophthalmitis,Known allergy to study medications ,Previous keratoplasty in involved eye Unwilling or unable to participate or follow up,Pregnant or breast-feeding females,Clinical evidence of herpetic keratitis,Age less than 16 years,Hepatitis B, C, HIV and Syphilis patients will be excluded from the study
|
|
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Method of Generating Random Sequence
|
Permuted block randomization, fixed |
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Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Time to re-epithelisation |
Outcome will be assessed on day 3, 7, 14, 21, 30,60 and 90. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Best spectacle-corrected visual acuity at 3 months
Infiltrate size or scar size
Ulcer depth
Time to ulcer healing
No of eyes requiring surgical procedures – cyanoacrylate glue adhesive or therapeutic penetrating keratoplasty or Amniotic Membrane Transplant.
|
Patients will be assessed on day 0, 3, 7, 14, 21, 30,60 & 90. Outcome will be recorded at 3 months. |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
20/01/2026 |
| 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="26"
Months="11"
Days="30" |
|
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
|
AIMS & OBJECTIVES To study the role of autologous serum in fungal corneal ulcers in addition to standard of care INCLUSION CRITERIA KOH stain positive Fungal corneal ulcers with mild to moderate grade in severity patients will be included in the study . Mild corneal ulcer includes ulcers with less than 2 mm in size, less than 20 percent depth of infiltrate Moderate corneal ulcer include ulcers with 2to5 mm in size, 20 to 50 percent depth of infiltrate EXCLUSION CRITERIA include Bacterial and mixed corneal ulcers, Ulcers warranting immediate surgical intervention (impending perforation or perforated ulcer), Endophthalmitis, Known allergy to study medications ,Previous keratoplasty in involved eye Unwilling or unable to participate or follow up,Pregnant or breast-feeding females, Clinical evidence of herpetic keratitis, Age less than 16 years and Hepatitis B, C, HIV and Syphilis patients INTERVENTION AND TREATMENT Total 40 patients who fulfilled the eligibility criteria will be randomly assigned in two groups with 20 patients in each group Group A will receive Standard antifungal therapy. Group B will receive Standard antifungal therapy with 50 percent Autologous serum eye drops in the dose of one drop 6 times a day. OUTCOME MEASURES Primary outcome Time to re-epithelisation Secondary outcomes include Best spectacle-corrected visual acuity at 3 months, Infiltrate size or scar size,,Ulcer depth, Time to ulcer healing. No of eyes requiring surgical procedures like cyanoacrylate glue adhesive or therapeutic penetrating keratoplasty or Amniotic Membrane Transplant. FOLLOW-UP Patients will be assessed at baseline, day 3, 7, 14, 21, 30,60 and 90. Outcome will be assessed at 3 months.
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