| CTRI Number |
CTRI/2025/08/092654 [Registered on: 08/08/2025] Trial Registered Prospectively |
| Last Modified On: |
07/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
To Compare if microscopy, culture or PCR is a better method to diagnose eye disease caused by Acanthamoeba |
|
Scientific Title of Study
|
Optimizing diagnosis of Acanthamoeba Keratitis : A comparative study of Microscopy , Culture and PCR from a tertiary care centre of South India |
| 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 Malavika Gopakumar |
| Designation |
Postgraduate |
| Affiliation |
Kasturba Medical College , Manipal |
| Address |
Department of Microbiology
Centre for Basic Sciences
Kasturba Medical College
Madhav Nagar
Manipal
Udupi KARNATAKA 576104 India |
| Phone |
09048991953 |
| Fax |
|
| Email |
malavika1.kmcmpl2024@learner.manipal.edu |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Vinay Khanna |
| Designation |
Associate Professor |
| Affiliation |
Kasturba Medical College , Manipal |
| Address |
Department of Microbiology
Centre for Basic Sciences
Kasturba Medical College
Madhav Nagar
Manipal
Udupi KARNATAKA 576104 India |
| Phone |
9964426900 |
| Fax |
|
| Email |
vinay.khanna@manipal.edu |
|
Details of Contact Person Public Query
|
| Name |
Dr Vinay Khanna |
| Designation |
Associate Professor |
| Affiliation |
Kasturba Medical College , Manipal |
| Address |
Department of Microbiology
Centre for Basic Sciences
Kasturba Medical College
Madhav Nagar
Manipal
Udupi KARNATAKA 576104 India |
| Phone |
9964426900 |
| Fax |
|
| Email |
vinay.khanna@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Institutional PG Thesis Fund , Kasturba Medical College , MAHE, Madhav Nagar,
Manipal,
Udupi
Karnataka
PINCODE 576104 |
|
|
Primary Sponsor
|
| Name |
Kasturba Medical College , Manipal |
| Address |
Kasturba Medical College ,
Madhav Nagar
Manipal
Udupi
Pincode 576104
|
| Type of Sponsor |
Private medical college |
|
|
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 |
| Dr Malavika Gopakumar |
Kasturba Medical College , Manipal |
Department of Microbiology,
Centre for Basic Sciences
Kasturba Medical College
Madhav Nagar,Eshwar Nagar
Manipal , Udupi
Kasturba Medical College
Madhav Nagar,
Manipal
Karnataka
PINCODE 576104 Udupi KARNATAKA |
09048991953
malavika1.kmcmpl2024@learner.manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
any diseases in eye other than acanthamoeba or infectious keratitis |
| Patients |
(1) ICD-10 Condition: H168||Other keratitis, (2) ICD-10 Condition: H160||Corneal ulcer, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
1.00 Day(s) |
| Age To |
95.00 Year(s) |
| Gender |
Both |
| Details |
Patients of any age and gender presenting with symptoms suggestive of Acanthamoeba
keratitis (pain, redness, photophobia, blurred vision). |
|
| ExclusionCriteria |
| Details |
1)Patients with a history of recent ocular surgery or trauma that may introduce non-Acanthamoeba pathogens.
2)Patients already receiving treatment for confirmed Acanthamoeba keratitis or any other severe
ocular infection. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1)To find out diagnostic accuracy in terms of Sensitivity , Specificity, PPV, NPV and accuracy for
microscopy , culture ,c-PCR for Acanthamoeba Keratitis
2)To find out proportion of Acanthamoeba Keratitis cases among clinically suspected infectious keratitis |
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Identification of risk factors associated with Acanthamoeba Keratitis in terms of delayed diagnosis , contact lens use,immunosuppression etc |
Baseline |
|
|
Target Sample Size
|
Total Sample Size="180" Sample Size from India="180"
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)
|
20/08/2025 |
| 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
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Acanthamoeba, a genus of free-living amoebae, inhabits diverse environments such as soil, freshwater, air, sewage, chlorinated water, medical equipment, and contact lens cases. These amoebae exist as trophozoites, actively feeding and proliferating under favorable conditions, but transform into highly resistant cysts under stress. While primarily bacterivorous, certain species, including Acanthamoeba castellanii, A. polyphaga, and A. hatchetti, exhibit pathogenic potential, causing keratitis and granulomatous amoebic encephalitis (GAE), particularly in immunocompromised individuals. GAE occurs when amoebae enter through wounds and disseminate to the brain. Acanthamoeba has also been detected on human skin, in the respiratory and gastrointestinal tracts, and in other hosts, highlighting its ecological adaptability and clinical significance.Acanthamoeba castellanii, A. polyphaga, and A. hatchetti are among the primary species implicated in Acanthamoeba keratitis (AK), a severe corneal infection that predominantly affects contact lens users due to improper lens hygiene. Hydrogen peroxide-based disinfectants effectively eliminate Acanthamoeba, whereas multipurpose solutions are largely ineffective. AK is often misdiagnosed due to its nonspecific symptoms, delaying treatment and increasing the risk of vision loss. First identified in 1973, its incidence rose in the 1980s with the widespread use of contact lenses, which account for 80–93% of cases globally. In contrast, in rural areas of developing countries, corneal trauma from vegetative matter is the primary risk factor, highlighting distinct epidemiological patterns.
The incidence of Acanthamoeba keratitis (AK) has risen significantly, with cases in the United States increasing tenfold from 2 million per year in 1988 to 20 million in 2003 among contact lens wearers. A study in South India analyzing over 38,000 infectious keratitis cases attributed 0.9% to AK. Despite this growing burden, global prevalence data remain limited, with most knowledge derived from localized studies and case reports, particularly those linked to contact lens use.
With the increasing incidence of Acanthamoeba keratitis (AK), along with diagnostic challenges and limited treatment options, further research is crucial. This study compares two diagnostic methods— Polymerase Chain Reaction (PCR) and culture isolation—for detecting Acanthamoeba species in AK cases. PCR is a highly sensitive technique that can identify even small amounts of Acanthamoeba DNA, making it particularly useful for early diagnosis. In contrast, culture isolation allows for species identification and provides biological insights by growing the amoeba from clinical samples. This study aims to evaluate the accuracy, effectiveness, and practical use of PCR versus culture isolation in AK diagnosis. Identifying the most reliable method will improve diagnostic protocols, enhance patient outcomes, and support public health strategies for better prevention. |