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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| standard medical therapy | Active Comparator | patients were continued on topical antifungal therapy namely Natamycin eye drops and voriconazole eye drops |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| collagen crosslinking group | Procedure | collagen crosslinking with riboflavin and Ultraviolet A |
|
| Measure | Description | Time Frame |
|---|---|---|
| size of infiltrate or scar, corneal structural integrity | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| visual acuity | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dr. Venkatesh Prajna, DNB, FRCS | Contact | +914524356100 | mutt@aravind.org | |
| Dr. Naveen R, MBBS, MS | Contact | +914524356100 | naveenmogana@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Dr. Venkatesh Prajna, DNB,FRCS | CHIEF CORNEA SERVICES | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aravind Eye Hospital | Recruiting | Madurai | Tamil Nadu | 624002 | India |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32557558 | Derived | 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. | |
| 25841317 | Derived | Uddaraju 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. |
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| ID | Term |
|---|---|
| D010866 | Natamycin |
| D065819 | Voriconazole |
| ID | Term |
|---|---|
| D018942 | Macrolides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
| D014230 | Triazoles |
| D001393 |
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| Topical anti-fungal therapy | Drug | topical antifungal medications like natamycin eye drops and voriconazole eye drops |
|
|
| Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |