Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06601101
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-09-15
Brief Title:
Effects of Topical Insulin on Corneal Epithelium Healing After Corneal Crosslinking in Patients With Keratoconus
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Effects of Topical Insulin on Corneal Epithelium Healing After Corneal Crosslinking in Patients With Keratoconus A Randomized Clinical Trial
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The cornea plays a fundamental role in vision being a complex tissue essential for ocular health In ophthalmological practice there are situations such as corneal crosslinking where damage to the corneal epithelium occurs Crosslinking is a surgical procedure aimed at strengthening collagen bonds in the corneal stroma to prevent the progression of keratoconus through the application of topical riboflavin followed by ultraviolet UV-A radiation To enhance the effectiveness of riboflavin and UV-A radiation the corneal epithelium needs to be removed which can cause postoperative pain and discomfort as well as increase the risk of complications such as infections scarring corneal opacities perforations and recurrent epithelial erosions Several growth factors play a role in epithelial healing and the discovery of insulin in the tear film and the presence of insulin and Insulin-Like Growth Factor IGF-1 receptors in the cornea has raised the hypothesis that insulin may modulate the corneas wound healing response Since then topical insulin has been used for various ocular pathologies including dry eye disease persistent epithelial defects and neurotrophic ulcers Based on this knowledge studies have been developed and promising results regarding the use of insulin in corneal healing have been reported providing a scientific foundation for the realization of this project The objective of this study is to evaluate the effect of insulin eye drops at a concentration of 50 IUml on epithelial healing in non-diabetic patients undergoing epithelial debridement for corneal crosslinking To this end a randomized double-masked clinical trial will be conducted with two groups one being the control group in which researchers will compare the epithelial healing rate in mm²h between the insulin group and the placebo group as the primary outcome Patients diagnosed with keratoconus and with an indication for the crosslinking procedure will be invited to participate As a result of the study it is expected to assess and quantify the impact of topical insulin on epithelial defect closure in patients undergoing crosslinking compared to placebo Topical insulin may contribute to early epithelial defect closure control of inflammation and prevention of complications that could significantly impact visual quality
Detailed Description:
Patients from the Keratoconus Clinic at the Hospital das Clínicas of UNICAMP diagnosed with keratoconus who are indicated for crosslinking will be evaluated regarding visual acuity refraction biomicroscopy automated keratometry Auto Kerato Refractometer KR 8000 Alcon Goldmann applanation tonometry corneal specular microscopy EM-3000 Tomey for endothelial cell count corneal tomography Pentacam HR 70900 Oculus and corneal optical coherence tomography SPECTRALIS Heidelberg Engineering
Once indicated for crosslinking participants will be informed by the assistants of the Keratoconus Clinic about the study Those who after being informed about all aspects of the crosslinking procedure and the study and sign the Informed Consent Form will be randomly divided into two groups of equal size and stratified by gender Group A will receive a prescription for insulin eye drops at a concentration of 50 IUml in a 05 methylcellulose vehicle 1 drop four times a day until complete corneal epithelial healing Group B will receive a prescription for 05 methylcellulose eye drops placebo 1 drop four times a day until complete corneal epithelial healing
The corneal crosslinking will be performed according to the standardized protocol of the UNICAMP Ophthalmology Department by third-year residents supervised by attending physicians and faculty members The procedure will be carried out in an outpatient setting The anesthetic technique is topical achieved through the application of 04 benoxinate hydrochloride eye drops Oxinest A blepharostat is then placed and 30 alcohol is applied to the corneal epithelium for 20 seconds demarcated by an 80mm optical zone marker to prevent alcohol leakage The alcohol is removed using an absorbent sponge Merocel followed by thorough cleaning of the ocular surface with 09 sodium chloride solution Next the corneal epithelium in the 80mm region is removed using a corneal scraper and the soaking procedure begins consisting of the instillation of 1 drop of 01 riboflavin for 30 minutes at 3-minute intervals After soaking the cornea is exposed to UV-A radiation at 9 mWcm² for 10 minutes with riboflavin instilled every 2 minutes during this period Once the procedure is completed 1 drop of moxifloxacin hydrochloride 545mgml Oftalmox Gbio antibiotic eye drops is applied and a silicone-hydrogel soft contact lens Air Optix Plus Hydraglyde Alcon is placed
Insulin eye drops 50 IUml Eye Pharma in Group A and placebo eye drops of 05 methylcellulose Eye Pharma in Group B will be prescribed every 6 hours to the eye that underwent the crosslinking procedure until complete corneal epithelialization occurs Both the insulin and methylcellulose eye drops will come in identical bottles making it impossible for the participants and the research team conducting the subsequent evaluations to distinguish between them In addition to these medications both groups will undergo postoperative treatment with prednisolone acetate 10mgml Ster Genom 1 drop every 6 hours moxifloxacin hydrochloride 545mgml Oftalmox Gbio 1 drop every 6 hours sodium hyaluronate 015 Hyabak Genom 1 drop every 4 hours and silicone-hydrogel contact lenses Air Optix Plus Hydraglyde Alcon These treatments are part of the standard postoperative care prescribed by the UNICAMP Department of Ophthalmology
The primary outcome is the time to complete corneal epithelial healing After epithelial healing the silicone-hydrogel contact lens will be removed and the antibiotic eye drop Oftalmox Gbio will be discontinued in both groups as well as the insulin eye drop in Group A and the methylcellulose eye drop in Group B At this point both groups will be prescribed sodium hyaluronate 015 and prednisolone acetate 10mgml Sodium hyaluronate an ocular lubricant will be continued until the 30th postoperative day and prednisolone acetate will be tapered every 7 days following this schedule every 8 hours every 12 hours every 24 hours and discontinuation
Third-year residents performing the procedures will not be masked but they will not conduct postoperative follow-up and evaluation which will be the responsibility of the research team Participants will be masked and the research team conducting the follow-up will also be masked In case of any suspected complications related to the crosslinking procedure an independent ophthalmologist from the cornea service will evaluate the patient without knowing to which group the patient belongs and will recommend the most appropriate treatment
Postoperative visits will take place on the 1st 2nd and 3rd days after the crosslinking procedure A fourth evaluation will occur on the 6th day post-procedure with follow-ups every 48 hours until the corneal epithelium is fully healed Typically this period is not expected to exceed one week in either group Subsequent follow-ups will occur on the 30th and 60th days post-procedure This follow-up schedule is routinely performed by the UNICAMP Department of Ophthalmology
At the 1st 2nd 3rd and 6th postoperative days the researcher responsible will document corneal status through photographs obtained using the Keratograph - OCULUS device If complete corneal healing has not occurred by the 6th day and further visits are needed this documentation will also be performed During these visits objective factors such as ocular hyperemia and the extent of the epithelial defect will be assessed For quantitative assessment of the epithelial defect the photographs obtained using the Keratograph - OCULUS will be analyzed using the ImageJ software httpsimagejnihgovij These visits will be carried out during the patients routine care lasting around 30 minutes On the 30th postoperative day biomicroscopy and applanation tonometry will be performed with a duration of approximately 15 minutes On the 60th postoperative day visual acuity refraction biomicroscopy corneal tomography corneal optical coherence tomography and endothelial cell count will be performed with the visit lasting around 45 minutes After this last visit the patient will be referred back to the Keratoconus Clinic for standard follow-up with decisions to be made by the UNICAMP Department of Ophthalmology
Once indicated for crosslinking participants will be informed by the assistants of the Keratoconus Clinic about the study Those who after being informed about all aspects of the crosslinking procedure and the study and sign the Informed Consent Form will be randomly divided into two groups of equal size and stratified by gender Group A will receive a prescription for insulin eye drops at a concentration of 50 IUml in a 05 methylcellulose vehicle 1 drop four times a day until complete corneal epithelial healing Group B will receive a prescription for 05 methylcellulose eye drops placebo 1 drop four times a day until complete corneal epithelial healing
The corneal crosslinking will be performed according to the standardized protocol of the UNICAMP Ophthalmology Department by third-year residents supervised by attending physicians and faculty members The procedure will be carried out in an outpatient setting The anesthetic technique is topical achieved through the application of 04 benoxinate hydrochloride eye drops Oxinest A blepharostat is then placed and 30 alcohol is applied to the corneal epithelium for 20 seconds demarcated by an 80mm optical zone marker to prevent alcohol leakage The alcohol is removed using an absorbent sponge Merocel followed by thorough cleaning of the ocular surface with 09 sodium chloride solution Next the corneal epithelium in the 80mm region is removed using a corneal scraper and the soaking procedure begins consisting of the instillation of 1 drop of 01 riboflavin for 30 minutes at 3-minute intervals After soaking the cornea is exposed to UV-A radiation at 9 mWcm² for 10 minutes with riboflavin instilled every 2 minutes during this period Once the procedure is completed 1 drop of moxifloxacin hydrochloride 545mgml Oftalmox Gbio antibiotic eye drops is applied and a silicone-hydrogel soft contact lens Air Optix Plus Hydraglyde Alcon is placed
Insulin eye drops 50 IUml Eye Pharma in Group A and placebo eye drops of 05 methylcellulose Eye Pharma in Group B will be prescribed every 6 hours to the eye that underwent the crosslinking procedure until complete corneal epithelialization occurs Both the insulin and methylcellulose eye drops will come in identical bottles making it impossible for the participants and the research team conducting the subsequent evaluations to distinguish between them In addition to these medications both groups will undergo postoperative treatment with prednisolone acetate 10mgml Ster Genom 1 drop every 6 hours moxifloxacin hydrochloride 545mgml Oftalmox Gbio 1 drop every 6 hours sodium hyaluronate 015 Hyabak Genom 1 drop every 4 hours and silicone-hydrogel contact lenses Air Optix Plus Hydraglyde Alcon These treatments are part of the standard postoperative care prescribed by the UNICAMP Department of Ophthalmology
The primary outcome is the time to complete corneal epithelial healing After epithelial healing the silicone-hydrogel contact lens will be removed and the antibiotic eye drop Oftalmox Gbio will be discontinued in both groups as well as the insulin eye drop in Group A and the methylcellulose eye drop in Group B At this point both groups will be prescribed sodium hyaluronate 015 and prednisolone acetate 10mgml Sodium hyaluronate an ocular lubricant will be continued until the 30th postoperative day and prednisolone acetate will be tapered every 7 days following this schedule every 8 hours every 12 hours every 24 hours and discontinuation
Third-year residents performing the procedures will not be masked but they will not conduct postoperative follow-up and evaluation which will be the responsibility of the research team Participants will be masked and the research team conducting the follow-up will also be masked In case of any suspected complications related to the crosslinking procedure an independent ophthalmologist from the cornea service will evaluate the patient without knowing to which group the patient belongs and will recommend the most appropriate treatment
Postoperative visits will take place on the 1st 2nd and 3rd days after the crosslinking procedure A fourth evaluation will occur on the 6th day post-procedure with follow-ups every 48 hours until the corneal epithelium is fully healed Typically this period is not expected to exceed one week in either group Subsequent follow-ups will occur on the 30th and 60th days post-procedure This follow-up schedule is routinely performed by the UNICAMP Department of Ophthalmology
At the 1st 2nd 3rd and 6th postoperative days the researcher responsible will document corneal status through photographs obtained using the Keratograph - OCULUS device If complete corneal healing has not occurred by the 6th day and further visits are needed this documentation will also be performed During these visits objective factors such as ocular hyperemia and the extent of the epithelial defect will be assessed For quantitative assessment of the epithelial defect the photographs obtained using the Keratograph - OCULUS will be analyzed using the ImageJ software httpsimagejnihgovij These visits will be carried out during the patients routine care lasting around 30 minutes On the 30th postoperative day biomicroscopy and applanation tonometry will be performed with a duration of approximately 15 minutes On the 60th postoperative day visual acuity refraction biomicroscopy corneal tomography corneal optical coherence tomography and endothelial cell count will be performed with the visit lasting around 45 minutes After this last visit the patient will be referred back to the Keratoconus Clinic for standard follow-up with decisions to be made by the UNICAMP Department of Ophthalmology
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None