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

NCT05905237 | Completed DMC

• 1 other identifier: 202200858B0A3
• Study Type: observational
• Target: 132
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Cataract; Myopia

Keywords

antioxidants

Outcome Measures

Primary Outcomes (10)

• Change of Total Antioxidant Capacity (TAC) in tears from Baseline to 1 week after surgery.

  Before the operation and 1 week after surgery.

• Change of Total Antioxidant Capacity (TAC) in tears from Baseline to 1 month after surgery.

  Before the operation and 1 month after surgery.

• Change of Total Antioxidant Capacity (TAC) in tears from Baseline to 3 months after surgery.

  Before the operation and 3 months after surgery.

• Change of Total Antioxidant Capacity (TAC) in tears from Baseline to 6 months after surgery.

  Before the operation and 6 months after surgery.

• Change of Ascorbic Acid (AA) in tears from Baseline to 1 week after surgery.

  Before the operation and 1 week after surgery.

• Change of Ascorbic Acid (AA) in tears from Baseline to 1 month after surgery.

  Before the operation and 1 month after surgery.

• Change of Ascorbic Acid (AA) in tears from Baseline to 3 months after surgery.

  Before the operation and 3 months after surgery.

• Change of Ascorbic Acid (AA) in tears from Baseline to 6 months after surgery.

  Before the operation and 6 months after surgery.

• Change of Total Antioxidant Capacity (TAC) in aqueous humor from Baseline to one day after surgery.

  During the operation and one day after surgery.

• Change of Ascorbic Acid (AA) in aqueous humor from Baseline to one day after surgery.

  During the operation and one day after surgery.

Secondary Outcomes (19)

• Examination of best corrected visual acuity (BCVA).

  Before the operation.

• Examination of uncorrected visual acuity (UCVA).

  Before the operation.

• Examination of uncorrected visual acuity (UCVA).

  One week after surgery.

• Examination of uncorrected visual acuity (UCVA).

  One month after surgery.

• Examination of intraocular pressure (IOP).

  Before the operation.

Interventions

Cataract surgery, Femtosecond-LASIK, SMILE PROCEDURE

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

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

A prospective, non-randomized trial was conducted at the Nobel Eye Clinic. This study included patients with the following conditions: (1) older than 20 years old (inclusive), (2) expected to undergo corneal refractive surgery or cataract surgery.

You may qualify if:

• over 20 years old (included)
• corneal refractive surgery or cataract surgery patients

You may not qualify if:

• patients with eye infections
• presence of severe retinal disease
• presence of severe eye injury or severe ptosis

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead
• Nobel Eye Institute: collaborator

Study Sites (2)

ChangGungMH

Taoyuan District, Taoyuan City, 333, Taiwan

Location

Nobel Eye Institute

Taipei, 106, Taiwan

Location

Related Publications (11)

• 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.

  PMID: 31377843 BACKGROUND

• 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.

  PMID: 23337404 BACKGROUND

• 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.

  PMID: 22520268 BACKGROUND

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

  PMID: 10803430 BACKGROUND

• 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.

  PMID: 22134364 BACKGROUND

• 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.

  PMID: 24952277 BACKGROUND

• 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.

  PMID: 23081981 BACKGROUND

• 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.

  PMID: 28714237 BACKGROUND

• 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.

  PMID: 32290365 BACKGROUND

• 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.

  PMID: 18547277 BACKGROUND

• 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.

  PMID: 38051678 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Tears are collected using Schirmer Tear Test Strips before and after surgery. Patients undergoing intraocular surgery lose their aqueous humor due to full thickness wounds. During operation, approximately 0.1-0.5 mL of the humor is collected into a microcentrifuge tube, and then, the humor leaked from wound at one day after surgery is also collected with an ophthalmic sponge. During the SMILE procedure, a sample of the corneal len (lenticule) will be produced, which is also placed in a microcentrifuge tube. All the above specimens were temporarily stored in liquid nitrogen and sent to the laboratory of the Research Building of Linkou Chang Gung Hospital on the day of acquisition for storage in a -80℃ refrigerator.

MeSH Terms

Conditions

Cataract; Myopia

Interventions

Cataract Extraction

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases; Refractive Errors

Intervention Hierarchy (Ancestors)

Refractive Surgical Procedures; Ophthalmologic Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Hung-Chi Chen, PhD

  Chang Gung Memorial Hospital

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 26, 2023
• First Posted: June 15, 2023
• Study Start: July 12, 2022
• Primary Completion: July 28, 2023
• Study Completion: July 28, 2023
• Last Updated: December 4, 2024

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

TW (2)