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the purpose of this study is to compare the efficacy and safety of a new method of corneal cross-linking that uses UV-A irradiation intensity of 9mW/cm2 for 7 minutes to well-known Accelerated corneal cross-linking (9 mW/cm2 UV-A irradiation for 10 minutes)
This study is a Prospective interventional clinical trial comparing two groups of mild to moderate progressive keratoconic patients; Control group will be treated with routine accelerated protocol of corneal cross-linking, while exposure time will be decreased in the experimental group.
we considered two groups of patients in our study:
All demographic data of patients, their uncorrected distance visual acuity (UCDVA), corrected distance visual acuity (BCDVA), sphere and cylinder refraction, keratometry readings (k1 and k2) and other topographic parameters of the patients before the procedure and at every follow up visit will be recorded.
Corneal hysteresis and resistance factor will be checked by Ocular response analyzer before surgery and will be rechecked at 6 month follow up.
Intraoperative pain will also be recorded based on the visual analog scale (VAS + FACES pain scale) immediately after the completion of surgery.
Confocal microscopy will be used to evaluate changes in corneal stromal collagen fibers and keratocytes following cross-linking at 3 and 6 and 12 month post op period.
All procedures will be done by a single surgeon. We will use topical anesthesia by tetracaine followed by mechanical epithelial debridement at a radius of 9 millimeters. Then riboflavin 0.1% combined with dextran 20 % will be instilled every 3 minutes for 25 minutes. A short irrigation of the surface with BSS (to avoid a layer of riboflavin on the cornea during irradiation) will be performed. Corneal thickness will be determined by ultrasound pachymetry. If needed, hypoosmolar solution will be used to swell the cornea over 400 µm. If 400 µm cannot be reached, then irradiation will not be performed. Then we will irradiate the eye by the UV A light source 5cm away from the eye with a light intensity of 9 mW/cm2 for 10 minutes in control group and 7 minutes in experimental group and riboflavin will be instilled after 5 minutes for further in both groups, followed by a short irrigation of the surface with BSS (to avoid a layer of riboflavin on the cornea during irradiation).
After the procedure we will apply a bandage contact lens for 5- 7 days and will prescribe topical betamethasone every 6 hours for 2 weeks, tapered to TDS, BID and HS weekly for a total duration 5 weeks. A topical antibiotic drop (Oftaquix every 6 hours) will be used for the first week.
Patients will be followed up at day 1, day 6, 1 month, 3 months and 6 months and 12 months after surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| experimental | Experimental | Radiation: adjusted corneal collagen cross-linking (9mW/cm2 UV-A irradiation for 7 minutes after 30 mitunes of riboflavin instillation) riboflavin 0.1%: after mechanical epithelial removal riboflavin drop will be instilled every 5 minutes for 30 minutes and then instillation will be continued during irradiation epithelial debridement: corneal epithelium will be removed by a cottons swab |
|
| control | Active Comparator | radiation: accelerated corneal collagen cross-linking (9mW/cm2 UV-A irradiation for 10 minutes after 30 minutes of riboflavin instillation) riboflavin 0.1%: after mechanical epithelial removal riboflavin drop will be instilled every 5 minutes for 30 minutes and then instillation will be continued during irradiation epithelial debridement: corneal epithelium will be removed by a cottons swab |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| adjusted corneal collagen cross-linking | Radiation | UV-A irradiation for 7 minutes |
| |
| Measure | Description | Time Frame |
|---|---|---|
| keratometric values on pentacam measured by Javal keratometer | one year | |
| best corrected visual acuity | one year | |
| uncorrected distant visual acuity | one year |
| Measure | Description | Time Frame |
|---|---|---|
| clinical refraction | one year | |
| endothelial cell count | one year |
| Measure | Description | Time Frame |
|---|---|---|
| corneal thickness | one year | |
| corneal hysteresis | one year | |
| corneal resistance factor |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Fateme Alipour, MD | Eye research center, Farabi eye hospital, Tehran university of medical science | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Farabi eye hospital | Tehran | Tehran Province | 1336616351 | Iran |
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| accelerated corneal collagen cross-linking |
| Radiation |
UV-A irradiation for 10 minutes |
|
| riboflavin 0.1% combined with dextran 20 % | Drug | after mechanical epithelial removal riboflavin drop will be instilled every 5 minutes for 30 minutes and then instillation will be continued during irradiation |
|
| epithelial debridement | Procedure | corneal epithelium will be removed by a cottons swab |
|
|
| one year |
| intraoperative discomfort and pain | Visual Analog scale | up to 1 hour |
| ID | Term |
|---|---|
| D007640 | Keratoconus |
| ID | Term |
|---|---|
| D003316 | Corneal Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D012256 | Riboflavin |
| D013357 | Subgingival Curettage |
| ID | Term |
|---|---|
| D005415 | Flavins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D006575 | Heterocyclic Compounds, 3-Ring |
| D003067 | Coenzymes |
| D045762 | Enzymes and Coenzymes |
| D010860 | Pigments, Biological |
| D001685 | Biological Factors |
| D010517 | Periodontics |
| D003813 | Dentistry |
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