Correlation Analysis of Lens Nucleus Density and Surgical Parameters Based on Ss-oct and Scheimpflug Technology

NCT05028530 | Unknown

• 1 other identifier: LZL nucleus density
• Study Type: observational
• Target: 53
• Locations: 1 country
• Sites: 1

Brief Summary

To study the correlation between three different lens nuclear opacity classification methods and intraoperative phacoemulsification parameters .

Conditions

Age-related Cataract

Keywords

cataract; nucleus density; phacoemulsification parameters; ss-oct; scheimpflug

Outcome Measures

Primary Outcomes (4)

• Lens nuclear opalescence(NO) and nuclear colour (NC)

  After the maximumly pupil dilation, the same experienced ophthalmologist examined all the eyes with slit-lamp digital cameras in dark conditions and scored the lens nuclear opalescence(NO) and nuclear colour (NC) on a scale of 0.1-6.9 according to LOCS III criteria.

  2021.12.30

• Pentacam mean nuclear density (PND)

  After the maximumly pupil dilation, Pentacam HR was used to acquire the Scheimpflug images of the lens, and the average density reading for the entire nucleus provided by PNS function was defined as Pentacam mean nuclear density (PND), ranging from 0% to 100%.

  2021.12.30

• Mean nucleus density (MND) of the lens presented by IOL-Master 700

  After the maximumly pupil dilation, the inspected eyes are asked to focus on the indicator light to obtain a high-definition image of the lens. The image is derived to the ImageJ software, and the contour of the lens nucleus is manually drawn. The pixel density of the image within the contour is measured, with a value range of 0-255.The mean pixel density within the region was used to represent the mean nucleus density (MND) of the lens presented by IOL-Master 700.For each eye, the SS-OCT nucleus density is defined as the average of six readings from the corresponding image.

  2021.12.30

• Intraoperative phacoemulsification parameters

  The intraoperative phacoemulsification parameters on the Centurion phacoemulsification machine (Alcon) screen were recorded after surgery.

  2021.12.30

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

In this study, age-related cataract patients who met the criteria for cataract surgery and underwent cataract surgery by the same surgeon in our hospital were included.

You may qualify if:

• Age-related cataracts performed by the same surgeon in our hospital;
• Pupil diameter can be enlarged more than 6 millimetre.

You may not qualify if:

• The pupil diameter cannot be dilated greater than 6mm;
• previously ocular surgery or laser treatment;
• history of ocular trauma;
• other ocular diseases such as keratoconus, glaucoma and retinal detachment;
• corneal opacities caused by leucoma, pterygium and other diseases;
• lens dislocation or complicated cataract surgery (any complications during/after the operations);
• poor fixation leading to low image quality or inability to cooperate with examinations.

Sponsors & Collaborators

• Wenzhou Medical University: lead

Study Sites (1)

Ophthalmology and Optometry Hospital

Wenzhou, Zhejiang, 325027, China

Location

Related Publications (7)

• Wang W, Zhang J, Gu X, Ruan X, Chen X, Tan X, Jin G, Wang L, He M, Congdon N, Liu Z, Luo L, Liu Y. Objective quantification of lens nuclear opacities using swept-source anterior segment optical coherence tomography. Br J Ophthalmol. 2022 Jun;106(6):790-794. doi: 10.1136/bjophthalmol-2020-318334. Epub 2021 Jan 13.

  PMID: 33441322 BACKGROUND

• Makhotkina NY, Berendschot TTJM, van den Biggelaar FJHM, Weik ARH, Nuijts RMMA. Comparability of subjective and objective measurements of nuclear density in cataract patients. Acta Ophthalmol. 2018 Jun;96(4):356-363. doi: 10.1111/aos.13694. Epub 2018 Mar 25.

  PMID: 29575599 BACKGROUND

• Lim SA, Shin JY, Chung SH. Useful Prediction of Phacodynamics by Scheimpflug Lens Densitometry in Patients over Age 70. Semin Ophthalmol. 2017;32(4):482-487. doi: 10.3109/08820538.2015.1120756. Epub 2016 Apr 19.

  PMID: 27092580 BACKGROUND

• Gupta M, Ram J, Jain A, Sukhija J, Chaudhary M. Correlation of nuclear density using the Lens Opacity Classification System III versus Scheimpflug imaging with phacoemulsification parameters. J Cataract Refract Surg. 2013 Dec;39(12):1818-23. doi: 10.1016/j.jcrs.2013.05.052.

  PMID: 24286839 BACKGROUND

• Chen D, Li Z, Huang J, Yu L, Liu S, Zhao YE. Lens nuclear opacity quantitation with long-range swept-source optical coherence tomography: correlation to LOCS III and a Scheimpflug imaging-based grading system. Br J Ophthalmol. 2019 Aug;103(8):1048-1053. doi: 10.1136/bjophthalmol-2018-312661. Epub 2018 Oct 12.

  PMID: 30315132 BACKGROUND

• Panthier C, de Wazieres A, Rouger H, Moran S, Saad A, Gatinel D. Average lens density quantification with swept-source optical coherence tomography: optimized, automated cataract grading technique. J Cataract Refract Surg. 2019 Dec;45(12):1746-1752. doi: 10.1016/j.jcrs.2019.07.033.

  PMID: 31856985 BACKGROUND

• Panthier C, Burgos J, Rouger H, Saad A, Gatinel D. New objective lens density quantification method using swept-source optical coherence tomography technology: Comparison with existing methods. J Cataract Refract Surg. 2017 Dec;43(12):1575-1581. doi: 10.1016/j.jcrs.2017.09.028.

  PMID: 29335103 BACKGROUND

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Study Officials

• Yune Zhao

  Ophthalmology and Optometry Hospital

  STUDY DIRECTOR

Central Study Contacts

Yune Zhao

CONTACT

8613819707056; zyehzeye@126.com

Lulu Chen

CONTACT

19883736563; 2951148901@qq.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice president of Eye Hospital of Wenzhou Medical University

Study Record Dates

• First Submitted: August 24, 2021
• First Posted: August 31, 2021
• Study Start: October 1, 2021
• Primary Completion: December 30, 2021
• Study Completion: December 30, 2021
• Last Updated: September 21, 2021

Record last verified: 2021-09

Locations

CN (1)