AzTrials
AzTrials

CataractNCT05905237

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

An observational study of Cataract and Myopia, run by Chang Gung Memorial Hospital at 2 sites in Taiwan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 20 years and olderHealthy volunteers can take part
Conditions the study is for
Cataract, Myopia
What is being tested?
Cataract surgery, Femtosecond-LASIK, SMILE
Type of treatment
Surgery or procedure
How many people
132 participants
Where
2 sitesTaiwan
Study dates
12 Jul 2022to 28 Jul 2023
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

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.

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

2 sites in 1 country.

Taiwan2 sites

  • Nobel Eye Institute

    Taipei, 106

  • ChangGungMH

    Taoyuan, Taoyuan City, 333

Other trials in Taiwan

About this study

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

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
Being tested
Cataract surgery, Femtosecond-LASIK, SMILE
Keywords
antioxidants
Medical subject headings
Cataract, Myopia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cataract surgery, Femtosecond-LASIK, SMILEProcedure or surgery

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

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: Before the operation and 1 week after surgery.

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

    Measured: Before the operation and 1 month after surgery.

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

    Measured: Before the operation and 3 months after surgery.

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

    Measured: Before the operation and 6 months after surgery.

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

    Measured: Before the operation and 1 week after surgery.

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

    Measured: Before the operation and 1 month after surgery.

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

    Measured: Before the operation and 3 months after surgery.

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

    Measured: Before the operation and 6 months after surgery.

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

    Measured: During the operation and one day after surgery.

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

    Measured: During the operation and one day after surgery.

Secondary outcomes (19)

  1. Examination of best corrected visual acuity (BCVA).

    Measured: Before the operation.

  2. Examination of uncorrected visual acuity (UCVA).

    Measured: Before the operation.

  3. Examination of uncorrected visual acuity (UCVA).

    Measured: One week after surgery.

  4. Examination of uncorrected visual acuity (UCVA).

    Measured: One month after surgery.

  5. Examination of intraocular pressure (IOP).

    Measured: Before the operation.

  6. Examination of intraocular pressure (IOP).

    Measured: One week after surgery.

  7. Examination of intraocular pressure (IOP).

    Measured: One month after surgery.

  8. Examination of central corneal thickness (CCT).

    Measured: Before the operation.

  9. Examination of central corneal thickness (CCT).

    Measured: One week after surgery.

  10. Examination of central corneal thickness (CCT).

    Measured: One month after surgery.

  11. Examination of axial length (AXL).

    Measured: Before the operation.

  12. Examination of anterior chamber depth (ACD).

    Measured: Before the operation.

  13. Examination of lens thickness (LT).

    Measured: Before the operation.

  14. Examination of manifest refraction.

    Measured: Before the operation.

  15. Examination of manifest refraction.

    Measured: One week after surgery.

  16. Examination of manifest refraction.

    Measured: One month after surgery.

  17. Examination of corneal curvature.

    Measured: Before the operation.

  18. Examination of corneal curvature.

    Measured: One week after surgery.

  19. Examination of corneal curvature.

    Measured: One month after surgery.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Jun 2023
  2. Study start12 Jul 2022
  3. Primary completion28 Jul 2023
  4. Study completion28 Jul 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
132 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05905237
Sponsor's protocol ID
202200858B0A3
Status last verified
Jul 2023
First submitted
26 May 2023
Last updated
4 Dec 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 31377843

  • 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.

    PubMed 23337404

  • 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.

    PubMed 22520268

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

    PubMed 10803430

  • 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.

    PubMed 22134364

  • 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.

    PubMed 24952277

  • 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.

    PubMed 23081981

  • 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.

    PubMed 28714237

  • 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.

    PubMed 32290365

  • 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.

    PubMed 18547277

  • 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.

    PubMed 38051678

Questions about this trial

What is this clinical trial studying?

An observational study of Cataract and Myopia, run by Chang Gung Memorial Hospital at 2 sites in Taiwan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change of Total Antioxidant Capacity (TAC) in tears from Baseline to 1 week after surgery. (time frame: Before the operation and 1 week after surgery.). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05905237, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2024.

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