Measurement of Antioxidant Activity on Postoperative Inflammation in Patients Undergoing Ophthalmic Surgery

Cataract Clinical Trial

Official title:

Effects of Laser Species and Ocular Antioxidant Activity on Postoperative Inflammation and Visual Prognosis in Patients Undergoing Ophthalmic Surgery - a Comparative Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05905237
• Other study ID #: 202200858B0A3
• Status: Recruiting
• Start date: July 12, 2022
• Est. completion date: September 6, 2024

Study information

• Verified date: September 2023
• Source: Chang Gung Memorial Hospital
• Contact: Hung-Chi Chen, PhD
• Phone: +886-975365859
• Email: mr3756[@]cgmh.org.tw
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This trial hypothesized that novel laser refractive surgery techniques (PRK, LASIK, SMILE) or laser-assisted cataract surgery (FLACAS) could suppress postoperative inflammation and improve recovery in patients by reducing oxidative stress generated by the surgical procedure. It is also intended to verify whether the new laser technology is necessary for clinical use in groups with low antioxidant activity through the detection of antioxidant activity in the eyes of patients.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: September 6, 2024
• Est. primary completion date: September 6, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

• over 20 years old (included)

• corneal refractive surgery or cataract surgery patients

Exclusion Criteria:

• patients with eye infections

• presence of severe retinal disease

• presence of severe eye injury or severe ptosis

Related Conditions & MeSH terms

• Cataract
• Inflammation
• Myopia

Intervention

Procedure:
• Cataract surgery, Femtosecond-LASIK, SMILE
Cataract surgery includes both conventional and femtosecond laser assisted. Femtosecond-LASIK and SMILE are options for patients to correct myopia.

Locations

Country	Name	City	State
Taiwan	Nobel Eye Institute	Taipei
Taiwan	ChangGungMH	Taoyuan	Taoyuan City

Sponsors (2)

Lead Sponsor	Collaborator
Chang Gung Memorial Hospital	Nobel Eye Institute

Country where clinical trial is conducted

Taiwan, 

References & Publications (10)

Barati E, Nikzad H, Karimian M. Oxidative stress and male infertility: current knowledge of pathophysiology and role of antioxidant therapy in disease management. Cell Mol Life Sci. 2020 Jan;77(1):93-113. doi: 10.1007/s00018-019-03253-8. Epub 2019 Aug 3. — View Citation

Horwath-Winter J, Kirchengast S, Meinitzer A, Wachswender C, Faschinger C, Schmut O. Determination of uric acid concentrations in human tear fluid, aqueous humour and serum. Acta Ophthalmol. 2009 Mar;87(2):188-92. doi: 10.1111/j.1755-3768.2008.01215.x. Epub 2008 Jun 11. — View Citation

Hsueh YJ, Meir YJ, Yeh LK, Wang TK, Huang CC, Lu TT, Cheng CM, Wu WC, Chen HC. Topical Ascorbic Acid Ameliorates Oxidative Stress-Induced Corneal Endothelial Damage via Suppression of Apoptosis and Autophagic Flux Blockage. Cells. 2020 Apr 11;9(4):943. doi: 10.3390/cells9040943. — View Citation

Kim EC, Meng H, Jun AS. N-Acetylcysteine increases corneal endothelial cell survival in a mouse model of Fuchs endothelial corneal dystrophy. Exp Eye Res. 2014 Oct;127:20-5. doi: 10.1016/j.exer.2014.06.002. Epub 2014 Jun 18. — View Citation

Kimoto M, Shima N, Yamaguchi M, Amano S, Yamagami S. Role of hepatocyte growth factor in promoting the growth of human corneal endothelial cells stimulated by L-ascorbic acid 2-phosphate. Invest Ophthalmol Vis Sci. 2012 Nov 9;53(12):7583-9. doi: 10.1167/iovs.12-10146. — View Citation

M Padua IR, P Valdetaro G, B Lima T, K Kobashigawa K, E S Silva P, Aldrovani M, M Padua PP, Laus JL. Effects of intracameral ascorbic acid on the corneal endothelium of dogs undergoing phacoemulsification. Vet Ophthalmol. 2018 Mar;21(2):151-159. doi: 10.1111/vop.12490. Epub 2017 Jul 17. — View Citation

Moreau KL, King JA. Protein misfolding and aggregation in cataract disease and prospects for prevention. Trends Mol Med. 2012 May;18(5):273-82. doi: 10.1016/j.molmed.2012.03.005. Epub 2012 Apr 19. — View Citation

Rosado-Adames N, Afshari NA. The changing fate of the corneal endothelium in cataract surgery. Curr Opin Ophthalmol. 2012 Jan;23(1):3-6. doi: 10.1097/ICU.0b013e32834e4b5f. — View Citation

Sacca SC, Roszkowska AM, Izzotti A. Environmental light and endogenous antioxidants as the main determinants of non-cancer ocular diseases. Mutat Res. 2013 Apr-Jun;752(2):153-171. doi: 10.1016/j.mrrev.2013.01.001. Epub 2013 Jan 19. — View Citation

Spector A. Review: Oxidative stress and disease. J Ocul Pharmacol Ther. 2000 Apr;16(2):193-201. doi: 10.1089/jop.2000.16.193. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of Total Antioxidant Capacity (TAC) in tears from Baseline to 1 week after surgery.		Before the operation and 1 week after surgery.
Primary	Change of Total Antioxidant Capacity (TAC) in tears from Baseline to 1 month after surgery.		Before the operation and 1 month after surgery.
Primary	Change of Total Antioxidant Capacity (TAC) in tears from Baseline to 3 months after surgery.		Before the operation and 3 months after surgery.
Primary	Change of Total Antioxidant Capacity (TAC) in tears from Baseline to 6 months after surgery.		Before the operation and 6 months after surgery.
Primary	Change of Ascorbic Acid (AA) in tears from Baseline to 1 week after surgery.		Before the operation and 1 week after surgery.
Primary	Change of Ascorbic Acid (AA) in tears from Baseline to 1 month after surgery.		Before the operation and 1 month after surgery.
Primary	Change of Ascorbic Acid (AA) in tears from Baseline to 3 months after surgery.		Before the operation and 3 months after surgery.
Primary	Change of Ascorbic Acid (AA) in tears from Baseline to 6 months after surgery.		Before the operation and 6 months after surgery.
Primary	Change of Total Antioxidant Capacity (TAC) in aqueous humor from Baseline to one day after surgery.		During the operation and one day after surgery.
Primary	Change of Ascorbic Acid (AA) in aqueous humor from Baseline to one day after surgery.		During the operation and one day after surgery.
Secondary	Examination of best corrected visual acuity (BCVA).		Before the operation.
Secondary	Examination of uncorrected visual acuity (UCVA).		Before the operation.
Secondary	Examination of uncorrected visual acuity (UCVA).		One week after surgery.
Secondary	Examination of uncorrected visual acuity (UCVA).		One month after surgery.
Secondary	Examination of intraocular pressure (IOP).		Before the operation.
Secondary	Examination of intraocular pressure (IOP).		One week after surgery.
Secondary	Examination of intraocular pressure (IOP).		One month after surgery.
Secondary	Examination of central corneal thickness (CCT).		Before the operation.
Secondary	Examination of central corneal thickness (CCT).		One week after surgery.
Secondary	Examination of central corneal thickness (CCT).		One month after surgery.
Secondary	Examination of axial length (AXL).		Before the operation.
Secondary	Examination of anterior chamber depth (ACD).		Before the operation.
Secondary	Examination of lens thickness (LT).		Before the operation.
Secondary	Examination of manifest refraction.		Before the operation.
Secondary	Examination of manifest refraction.		One week after surgery.
Secondary	Examination of manifest refraction.		One month after surgery.
Secondary	Examination of corneal curvature.		Before the operation.
Secondary	Examination of corneal curvature.		One week after surgery.
Secondary	Examination of corneal curvature.		One month after surgery.