The Effect of Wearing Orthokeratology on Objective Visual Quality

Visual Quality Clinical Trial

Official title:

The Effect of Wearing Orthokeratology on Objective Visual Quality

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04929119
• Other study ID #: 2021jnU
• Status: Recruiting
• Start date: March 7, 2021
• Est. completion date: March 31, 2022

Study information

• Verified date: June 2021
• Source: First Affiliated Hospital of Jinan University
• Contact: xiaoyong Liu
• Phone: 86-13760638809
• Email: jndxlxy[@]163.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

The visual quality indexes of these patients before and after Orthokeratology treatment were compared: 4 mm higher strehl ratio (SR) , 4 mm higher order corneal aberrations (Hoa ) , Spherical Aberrations (SA) , Comas, Trefoil Aberrations (RMS) , corneal aspheric index (Q, e) , corneal surface regularity index (SRI) , corneal surface asymmetry index (Sai)

Description:

USING OPD-SCAN III instrument method: Drag The joystick to focus on the screen prompt, and the device automatically starts to measure the aberration when the yellow focus is shown; Simk will change from black to rose red when the aberration is measured to start measuring the corneal topography, prompting the patient to blink the tear film evenly and press the button on the joystick when the focus is completed.The following data were obtained and analyzed: 4 mm high order STREHL rate (SR) , 4 mm high order corneal aberration (Hoa ) , Spherical Aberration (SA) , Coma Aberration (Coma) , Trefoil Aberration (RMS) , corneal aspheric index (Q, e) , corneal surface regularity index (SRI) , corneal surface asymmetry index (Sai)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: March 31, 2022
• Est. primary completion date: March 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 25 Years

Eligibility

Inclusion Criteria:

• The subject understands the purpose of this clinical trial and is willing, able and committed to return to the center for all clinical trial visits and to complete all research related procedures

Exclusion Criteria:

• 1. Associated with corneal abnormalities, such as active Keratitis (corneal infection) , corneal dystrophy, Keratoconus, corneal Leukoplakia, corneal hypoesthesia, or previous corneal surgery, or a history of corneal trauma;

• 2, there are other eye diseases, such as Dacryocystitis, dry eye disease, conjunctivitis, blepharitis, Uveitis, and other inflammation, Glaucoma, cataracts, fundus disease, eye tumors, ocular trauma, squint patients;

• 3. A history of allergy to contact lens or contact Lens Solution.

• 4. Test results indicate that subjects with contraindications or unsuitable for wearing Orthokeratology.

Related Conditions & MeSH terms

• Visual Quality

Locations

Country	Name	City	State
China	First Affiliated Hospital of Jinan University	Guangdong	Guangzhou

Sponsors (1)

Lead Sponsor	Collaborator
XiaoYong Liu

Country where clinical trial is conducted

China, 

References & Publications (5)

Goldstone RN, Yildiz EH, Fan VC, Asbell PA. Changes in higher order wavefront aberrations after contact lens corneal refractive therapy and LASIK surgery. J Refract Surg. 2010 May;26(5):348-55. doi: 10.3928/1081597X-20100218-03. Epub 2010 May 19. — View Citation

Holden BA, Fricke TR, Wilson DA, Jong M, Naidoo KS, Sankaridurg P, Wong TY, Naduvilath TJ, Resnikoff S. Global Prevalence of Myopia and High Myopia and Temporal Trends from 2000 through 2050. Ophthalmology. 2016 May;123(5):1036-42. doi: 10.1016/j.ophtha.2016.01.006. Epub 2016 Feb 11. Review. — View Citation

Lian Y, Shen M, Huang S, Yuan Y, Wang Y, Zhu D, Jiang J, Mao X, Wang J, Lu F. Corneal reshaping and wavefront aberrations during overnight orthokeratology. Eye Contact Lens. 2014 May;40(3):161-8. doi: 10.1097/ICL.0000000000000031. — View Citation

Swarbrick HA. Orthokeratology review and update. Clin Exp Optom. 2006 May;89(3):124-43. Review. — View Citation

Yin Y, Zhao Y, Wu X, Jiang M, Xia X, Chen Y, Song W, Hu S, Zhou X, Young K, Wen D. One-year effect of wearing orthokeratology lenses on the visual quality of juvenile myopia: a retrospective study. PeerJ. 2019 May 30;7:e6998. doi: 10.7717/peerj.6998. eCollection 2019. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	4 mm high-order strehl ratio	Objective visual quality 1	6 months
Primary	4 mm high-order corneal aberrations (Hoa) in Microns	Objective visual quality 2	6 months
Primary	Spherical Aberrations (SA) in Microns	Objective visual quality 3	6 months
Primary	Coma Aberrations (COMA) in Microns	Objective visual quality 4	6 months
Primary	Trefoil Aberrations in Microns	Objective visual quality 5	6 months
Primary	corneal aspheric index(Q)	Objective visual quality 6	6 months
Primary	corneal aspheric index(e)	Objective visual quality 7	6 months
Primary	corneal surface regularity index (SRI)	Objective visual quality 8	6 months
Primary	corneal surface asymmetry index (Sai)	Objective visual quality 9	6 months