Clinical trial NCT05028530: Correlation Analysis of Lens Nucleus Density and Surgical Parameters Based on Ss-oct and Scheimpflug Technology
Official title: Correlation Analysis of Lens Nucleus Density and Surgical Parameters Based on Long-range Swept-source Optical Coherence Tomography and Scheimpflug Technology
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Age-related Cataract
Keywords: cataract
nucleus density
phacoemulsification parameters
ss-oct
scheimpflug
Lead sponsor: Wenzhou Medical University
Sponsor class: OTHER
First posted: 2021-08-31
Enrollment: 53
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
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.

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

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Lens nuclear opalescence(NO) and nuclear colour (NC)
timeFrame: 2021.12.30
measure: Pentacam mean nuclear density (PND)
timeFrame: 2021.12.30
measure: Mean nucleus density (MND) of the lens presented by IOL-Master 700
timeFrame: 2021.12.30
measure: Intraoperative phacoemulsification parameters
timeFrame: 2021.12.30
Secondary outcomes:
Other outcomes:
Locations:
city: Wenzhou
country: China
facility: Ophthalmology and Optometry Hospital
state: Zhejiang
Study officials:
affiliation: Ophthalmology and Optometry Hospital
name: Yune Zhao
role: STUDY_DIRECTOR
References:
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. 2022 Jun;106(6):790-794. doi: 10.1136/bjophthalmol-2020-318334. Epub 2021 Jan 13.
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.
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.
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.
citation: 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.
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.
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.