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

NCT ID: NCT05905237

Last Updated: 2024-12-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

132 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-07-12

Study Completion Date

2023-07-28

Brief Summary

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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.

Detailed Description

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Conditions

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Cataract Myopia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Nobel Eye Institute

UNKNOWN

Sponsor Role collaborator

Chang Gung Memorial Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Hung-Chi Chen, PhD

Role: STUDY_CHAIR

Chang Gung Memorial Hospital

Locations

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ChangGungMH

Taoyuan District, Taoyuan City, Taiwan

Site Status

Nobel Eye Institute

Taipei, , Taiwan

Site Status

Countries

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Taiwan

References

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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.

Reference Type BACKGROUND
PMID: 31377843 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23337404 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22520268 (View on PubMed)

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

Reference Type BACKGROUND
PMID: 10803430 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22134364 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24952277 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23081981 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28714237 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32290365 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18547277 (View on PubMed)

Chen HC, Yang SF, Lee CY, Hsueh YJ, Huang JY, Chang CK. Differences in change of post-operative antioxidant levels between laser-assisted lenticule extraction and femtosecond laser in situ keratomileusis. J Cell Mol Med. 2024 Jan;28(2):e18069. doi: 10.1111/jcmm.18069. Epub 2023 Dec 5.

Reference Type DERIVED
PMID: 38051678 (View on PubMed)

Other Identifiers

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202200858B0A3

Identifier Type: -

Identifier Source: org_study_id