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

Age-related Cataract Clinical Trial

Official title:

Correlation Analysis of Lens Nucleus Density and Surgical Parameters Based on Long-range Swept-source Optical Coherence Tomography and Scheimpflug Technology

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05028530
• Other study ID #: LZL nucleus density
• Status: Not yet recruiting
• Start date: October 1, 2021
• Est. completion date: December 30, 2021

Study information

• Verified date: September 2021
• Source: Wenzhou Medical University
• Contact: Yune Zhao
• Phone: 8613819707056
• Email: zyehzeye[@]126.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Description:

Slit-lamp lens images, Pentacam and IOL-Master 700 images were collected in patients with dilated pupil before cataract surgery, and phacoemulsification parameters on the Centurion phacoemulsification machine (Alcon) screen were recorded. Spearman correlation analysis was used to analyze the correlation between lens nuclear density and phacoemulsification parameters based on SS-OCT and Scheimpflug techniques.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 53
• Est. completion date: December 30, 2021
• Est. primary completion date: December 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

1. Age-related cataracts performed by the same surgeon in our hospital;

2. Pupil diameter can be enlarged more than 6 millimetre.

Exclusion Criteria:

1. The pupil diameter cannot be dilated greater than 6mm;

2. previously ocular surgery or laser treatment;

3. history of ocular trauma;

4. other ocular diseases such as keratoconus, glaucoma and retinal detachment;

5. corneal opacities caused by leucoma, pterygium and other diseases;

6. lens dislocation or complicated cataract surgery (any complications during/after the operations);

7. poor fixation leading to low image quality or inability to cooperate with examinations.

Related Conditions & MeSH terms

• Age-related Cataract
• Cataract

Locations

Country	Name	City	State
China	Ophthalmology and Optometry Hospital	Wenzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Wenzhou Medical University

Country where clinical trial is conducted

China, 

References & Publications (7)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. 2021 Jan 13. pii: bjophthalmol-2020-318334. doi: 10.1136/bjophthalmol-2020-318334. [Epub ahead of print] — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	Intraoperative phacoemulsification parameters	The intraoperative phacoemulsification parameters on the Centurion phacoemulsification machine (Alcon) screen were recorded after surgery.	2021.12.30