Mycotic Corneal UlcerNCT02328053
Clinical & Visual Outcomes of Collagen Cross Linking for Fungal Keratitis
A study testing collagen crosslinking group and Topical anti-fungal therapy in people with Mycotic Corneal Ulcer, run by Aravind Eye Care System at 1 site in India.
Trial summary
The study is a randomised control trial to assess the visual and clinical outcomes of collagen cross linking in fungal keratitis. Fungal keratitis is a major cause of corneal blindness in India and the therapeutic options available are minimal to handle the advanced complications and sequalae caused by the disease.The… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Mycotic Corneal Ulcer
- What is being tested?
- collagen crosslinking group and Topical anti-fungal therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteIndia
- Study dates
- Feb 2014to Sep 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ulcer size more than 5 mm
- Ulcer depth upto 70% of stromal depth
- Corneal thickness of 400 microns and above
Who cannot join
- Corneal thickness of below 400 microns
- Ulcers involving the limbus
- Pregnant women
- Children below the age of 18 years
Trial locations and contacts
1 site in 1 country.
India1 site, 1 recruiting
- Recruiting
Aravind Eye Hospital
Madurai, Tamil Nadu, 624002
Dr. Venkatesh Prajna, DNB, FRCS, +914524356100, mutt@aravind.org
About this study
The study is a randomised control trial to assess the visual and clinical outcomes of collagen cross linking in fungal keratitis. Fungal keratitis is a major cause of corneal blindness in India and the therapeutic options available are minimal to handle the advanced complications and sequalae caused by the disease.The antimicrobial and tissue remodeling role of corneal cross linking was demonstrated by several studies earlier,we anted to specifically assess the role of corneal cross linking in non resolving fungal keratitis in prevention of perforation and enhancement of healing process.
Read the detailed description
Patients with culture positive deep stromal fungal keratitis not responding to appropriate medical therapy for a period of two weeks were randomized to receive or not receive adjuvant CXL. The medical therapy was continued in both the groups and were followed up for 6 weeks after randomization. Healing of the ulcer was taken as successful outcome, while perforation and increase in ulcer size of more than 2 sq.mm from the baseline was considered as treatment failure.
- Conditions
- Mycotic Corneal Ulcer
- Being tested
- collagen crosslinking group, Topical anti-fungal therapy
- Keywords
- fungal keratitis, collagen cross linking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
collagen crosslinking groupProcedure or surgery
Also called CXL, C3R
collagen crosslinking with riboflavin and Ultraviolet A
Topical anti-fungal therapyDrug
Also called natamycin, voriconazole
topical antifungal medications like natamycin eye drops and voriconazole eye drops
| Study group | Role | What they receive |
|---|---|---|
| Collagen crosslinking group | Experimental | patients not resolving to standard antifungal therapy were assigned to receive adjuvant collagen crosslinking with riboflavin and Ultraviolet-A along with topical medical therapy Receives: Procedure: collagen crosslinking group; Drug: Topical anti-fungal therapy |
| standard medical therapy | Active comparator | patients were continued on topical antifungal therapy namely Natamycin eye drops and voriconazole eye drops Receives: Drug: Topical anti-fungal therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
size of infiltrate or scar, corneal structural integrity
Measured: 6 months
Secondary outcomes (1)
visual acuity
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2014 (estimated)
- Study startFeb 2014
- Primary completionJul 2015 (estimated)
- Study completionSep 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Mycotic Corneal UlcerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aravind Eye Care System
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr.N.Venkatesh Prajna, Aravind Eye Care System
- Investigators
- Dr. Venkatesh Prajna, DNB,FRCS, Principal investigator, CHIEF CORNEA SERVICES
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02328053
- Sponsor's protocol ID
- IRB2013019CLI
- Status last verified
- Dec 2014
- First submitted
- 13 Dec 2014
- Last updated
- 31 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Davis SA, Bovelle R, Han G, Kwagyan J. Corneal collagen cross-linking for bacterial infectious keratitis. Cochrane Database Syst Rev. 2020 Jun 17;6(6):CD013001. doi: 10.1002/14651858.CD013001.pub2.
PubMed 32557558Uddaraju M, Mascarenhas J, Das MR, Radhakrishnan N, Keenan JD, Prajna L, Prajna VN. Corneal Cross-linking as an Adjuvant Therapy in the Management of Recalcitrant Deep Stromal Fungal Keratitis: A Randomized Trial. Am J Ophthalmol. 2015 Jul;160(1):131-4.e5. doi: 10.1016/j.ajo.2015.03.024. Epub 2015 Apr 1.
PubMed 25841317
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical & Visual Outcomes of Collagen Cross Linking for Fungal Keratitis
- ClinicalTrials.gov ID
- NCT02328053
- Acronym / sponsor ID
- IRB2013019CLI
- Conditions
- Mycotic Corneal Ulcer
- Keywords
- fungal keratitis, collagen cross linking
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Aravind Eye Care SystemUniversity, hospital or other
- Study start
- Feb 2014
- Primary completion
- Jul 2015 (estimated)
- Study completion
- Sep 2015 (estimated)
- First posted
- 31 Dec 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study is a randomised control trial to assess the visual and clinical outcomes of collagen cross linking in fungal keratitis. Fungal keratitis is a major cause of corneal blindness in India and the therapeutic options available are minimal to handle the advanced complications and sequalae caused by the disease.The antimicrobial and tissue remodeling role of corneal cross linking was demonstrated by several studies earlier,we anted to specifically assess the role of corneal cross linking in non resolving fungal keratitis in prevention of perforation and enhancement of healing process.
Detailed description
Patients with culture positive deep stromal fungal keratitis not responding to appropriate medical therapy for a period of two weeks were randomized to receive or not receive adjuvant CXL. The medical therapy was continued in both the groups and were followed up for 6 weeks after randomization. Healing of the ulcer was taken as successful outcome, while perforation and increase in ulcer size of more than 2 sq.mm from the baseline was considered as treatment failure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Collagen crosslinking group | Experimental | Procedure: collagen crosslinking group, Drug: Topical anti-fungal therapypatients not resolving to standard antifungal therapy were assigned to receive adjuvant collagen crosslinking with riboflavin and Ultraviolet-A along with topical medical therapy |
| standard medical therapy | Active comparator | Drug: Topical anti-fungal therapypatients were continued on topical antifungal therapy namely Natamycin eye drops and voriconazole eye drops |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Ulcer size more than 5 mm
- Ulcer depth upto 70% of stromal depth
- Corneal thickness of 400 microns and above
Key exclusion criteria (4 listed)
- Corneal thickness of below 400 microns
- Ulcers involving the limbus
- Pregnant women
- Children below the age of 18 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| collagen crosslinking groupAlso: CXL, C3Rcollagen crosslinking with riboflavin and Ultraviolet A | Procedure or surgery | Collagen crosslinking group |
| Topical anti-fungal therapyAlso: natamycin, voriconazoletopical antifungal medications like natamycin eye drops and voriconazole eye drops | Drug | Collagen crosslinking group, standard medical therapy |
Primary outcome
size of infiltrate or scar, corneal structural integrity
Time frame: 6 months
1 secondary outcome
visual acuity
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2014.
- Derived from this study: PubMed 32557558Davis SA, Bovelle R, Han G, Kwagyan J. Corneal collagen cross-linking for bacterial infectious keratitis. Cochrane Database Syst Rev. 2020 Jun 17;6(6):CD013001. doi: 10.1002/14651858.CD013001.pub2.
- Derived from this study: PubMed 25841317Uddaraju M, Mascarenhas J, Das MR, Radhakrishnan N, Keenan JD, Prajna L, Prajna VN. Corneal Cross-linking as an Adjuvant Therapy in the Management of Recalcitrant Deep Stromal Fungal Keratitis: A Randomized Trial. Am J Ophthalmol. 2015 Jul;160(1):131-4.e5. doi: 10.1016/j.ajo.2015.03.024. Epub 2015 Apr 1.
Related trials for Mycotic Corneal Ulcer
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Fungal Ulcer Treatment Augmented With Natamycin and Cyclosporine A
Fungal Keratitis, Corneal Ulcer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr. Venkatesh Prajna, DNB,FRCS principal investigator
CHIEF CORNEA SERVICES
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing collagen crosslinking group and Topical anti-fungal therapy in people with Mycotic Corneal Ulcer, run by Aravind Eye Care System at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dr. Venkatesh Prajna, DNB, FRCS (+914524356100, mutt@aravind.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
size of infiltrate or scar, corneal structural integrity (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02328053, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Dec 2014.