Qualitative and Quantitative Endothelium Changes After Cataract Surgery: Ultrasound Phacoemulsification vs Nanolaser Technique

NCT05886283 | Completed DMC

• 1 other identifier: 14-03-2023
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

Brief Summary

Purpose: The aim of this study was to evaluate corneal endothelial cell density and morphology, central corneal thickness, and best visual acuity using US phacoemulsification or Nanosecond laser technique. Setting: Department of ophthalmology, Nabeul, Tunisia. Design: Prospective cohort study. Methods: The study included eyes with nuclear cataract density grade 1, 2, 3, or 4 according to LOCS III, divided into two groups; Group 1 had conventional US, and group 2 had nanosecond laser. The Endothelial Cell Density (ECD), coefficient of variation (CoV) in cell size, percentage of hexagonal cells, central corneal thickness and best visual acuity were evaluated over 24 months.

Conditions

Effect of Cataract Surgery on Corneal Endothelium; About 2 Techniques

Keywords

cataract surgery; phacoemulsification; Nanosecond laser; endothelial cells density

Outcome Measures

Primary Outcomes (7)

• Endothelial cell density (ECD)

  The endothelium of the central cornea was examined using a non-contact specular microscope (SM) (TOMEY CORP EM-4000).

  2 years

• Percentage of endothelial cell loss (ECL)

  ECL was evaluated using a non-contact specular microscope (SM) (TOMEY CORP EM-4000).

  2 years

• Mean percentage of hexagonal cells

  The mean percentage of hexagonal cells was evaluated using a non-contact specular microscope (SM) (TOMEY CORP EM-4000).

  2 years

• Mean coefficient of variance (CoV)

  CoV was evaluated using a non-contact specular microscope (SM) (TOMEY CORP EM-4000).

  2 years

• Central corneal thickness (CCT)

  CCT was evaluated using a non-contact specular microscope (SM) (TOMEY CORP EM-4000).

  2 years

• Uncorrected visual acuity (UVA)

  UVA was evaluated at 1 day post-operatively

  2 years

• Best corrected visual acuity (BCVA)

  2 years

Study Arms (2)

ultrasound phaco groupe

ACTIVE COMPARATOR

this group had US PHACO using the phaco-chop technique (Stellaris PC: Bausch + Lomb®)

Procedure: phacoemulsification; Procedure: utrasound phacoemulsification

nanolaser phaco group

ACTIVE COMPARATOR

this group underwent an NL PHACO (Cetus A.R.C. Laser system®)

Procedure: phacoemulsification; Procedure: nanolaser phacoemulsification

Interventions

phacoemulsification PROCEDURE

we started with a clear corneal incision of 2.2 mm at 9 o'clock and a port incision of 1 at 2 o'clock. Continuous Circular Capsulorhexis of 6 mm was performed under the same ophthalmic viscosurgical device. A hydro dissection was performed, then followed by phacoemulsification. the Nucleus has been treated using 2 different techniques After bimanual infusion/aspiration cortex removal and Visco expansion of the capsular bag, a hydrophobic single-piece: AcrySof acrylic IOL was implanted.

nanolaser phaco group; ultrasound phaco groupe

utrasound phacoemulsification PROCEDURE

US group:The nucleus was held with the phaco tip at a high vacuum. The phaco choppe was drawn towards the phaco tip to cleave it by a manual separation between the two instruments. The fragments were then aspirated with phaco power. The standard parameters used during phacoemulsification were a vacuum level of 500 mmHg, pressurized irrigation of 90 mmHg, and 40% of phaco power

ultrasound phaco groupe

nanolaser phacoemulsification PROCEDURE

Laser group: The nucleus was fragmented using the shockwaves emanating from the phaco tip and then aspirated. The phaco chopper was used to accelerate the mechanical fragmentation of the nucleus and minimize the dissipated energy.

nanolaser phaco group

Eligibility Criteria

• Age: 50 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Senile cataract.
• Preoperative endothelial cell count (ECC) less than 1500 cells/mm2.
• Pathological alterations of the anterior segment such as corneal opacities, cornea Guttata, uveitis, pseudoexfoliative syndrome, glaucoma, high myopia axil length (≥ 26 mm), or suffering from chronic pathologies that may affect corneal endothelium

You may not qualify if:

• Conversion from NL PHACO to US PHACO.
• Surgery was complicated with capsular rent and vitreous loss.

Sponsors & Collaborators

• University Tunis El Manar: lead

Study Sites (1)

Mohamed Taher Maamouri Hospital

Nabeul, 8000, Tunisia

Location

Related Publications (1)

• Zbiba W, Kharrat M, Sayadi S, Kallel Z, Marzouk G. Qualitative and quantitative endothelium changes after cataract surgery: ultrasound phacoemulsification vs. nanolaser technique. Front Med (Lausanne). 2023 Sep 21;10:1097404. doi: 10.3389/fmed.2023.1097404. eCollection 2023.

  PMID: 37809334 DERIVED

MeSH Terms

Interventions

Phacoemulsification

Intervention Hierarchy (Ancestors)

Cataract Extraction; Refractive Surgical Procedures; Ophthalmologic Surgical Procedures; Surgical Procedures, Operative; Ultrasonic Surgical Procedures

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: the investigator does not know the technique used to operate on the cataract during the follow-up
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Model Details: A randomized prospective, uncontrolled cohort study

Study Record Dates

• First Submitted: April 12, 2023
• First Posted: June 2, 2023
• Study Start: March 1, 2017
• Primary Completion: May 31, 2020
• Study Completion: December 30, 2020
• Last Updated: June 5, 2023

Record last verified: 2023-06

Locations

TU (1)