Qualitative and Quantitative Endothelium Changes After Cataract Surgery: Ultrasound Phacoemulsification vs Nanolaser Technique
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ClinicalTrials.gov Identifier: NCT05886283 |
Recruitment Status :
Completed
First Posted : June 2, 2023
Last Update Posted : June 5, 2023
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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.
Condition or disease | Intervention/treatment | Phase |
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Effect of Cataract Surgery on Corneal Endothelium; About 2 Techniques | Procedure: phacoemulsification Procedure: utrasound phacoemulsification Procedure: nanolaser phacoemulsification | Not Applicable |
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Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 74 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Intervention Model Description: | A randomized prospective, uncontrolled cohort study |
Masking: | Single (Investigator) |
Masking Description: | the investigator does not know the technique used to operate on the cataract during the follow-up |
Primary Purpose: | Treatment |
Official Title: | Qualitative and Quantitative Endothelium Changes After Cataract Surgery: Ultrasound Phacoemulsification vs Nanolaser Technique |
Actual Study Start Date : | March 1, 2017 |
Actual Primary Completion Date : | May 31, 2020 |
Actual Study Completion Date : | December 30, 2020 |
Arm | Intervention/treatment |
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Active Comparator: ultrasound phaco groupe
this group had US PHACO using the phaco-chop technique (Stellaris PC: Bausch + Lomb®)
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Procedure: phacoemulsification
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. Procedure: utrasound phacoemulsification 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 |
Active Comparator: nanolaser phaco group
this group underwent an NL PHACO (Cetus A.R.C. Laser system®)
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Procedure: phacoemulsification
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. Procedure: nanolaser phacoemulsification 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. |
- Endothelial cell density (ECD) [ Time Frame: 2 years ]The endothelium of the central cornea was examined using a non-contact specular microscope (SM) (TOMEY CORP EM-4000).
- Percentage of endothelial cell loss (ECL) [ Time Frame: 2 years ]ECL was evaluated using a non-contact specular microscope (SM) (TOMEY CORP EM-4000).
- Mean percentage of hexagonal cells [ Time Frame: 2 years ]The mean percentage of hexagonal cells was evaluated using a non-contact specular microscope (SM) (TOMEY CORP EM-4000).
- Mean coefficient of variance (CoV) [ Time Frame: 2 years ]CoV was evaluated using a non-contact specular microscope (SM) (TOMEY CORP EM-4000).
- Central corneal thickness (CCT) [ Time Frame: 2 years ]CCT was evaluated using a non-contact specular microscope (SM) (TOMEY CORP EM-4000).
- Uncorrected visual acuity (UVA) [ Time Frame: 2 years ]UVA was evaluated at 1 day post-operatively
- Best corrected visual acuity (BCVA) [ Time Frame: 2 years ]
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Ages Eligible for Study: | 50 Years to 90 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
-Senile cataract.
Non Inclusion Criteria:
- 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
Exclusion Criteria:
- Conversion from NL PHACO to US PHACO.
- Surgery was complicated with capsular rent and vitreous loss.
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05886283
Tunisia | |
Mohamed Taher Maamouri Hospital | |
Nabeul, Tunisia, 8000 |
Responsible Party: | Walid Zbiba, professor, University Tunis El Manar |
ClinicalTrials.gov Identifier: | NCT05886283 |
Other Study ID Numbers: |
14-03-2023 |
First Posted: | June 2, 2023 Key Record Dates |
Last Update Posted: | June 5, 2023 |
Last Verified: | June 2023 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
cataract surgery phacoemulsification Nanosecond laser endothelial cells density |
Cataract Capsule Opacification Lens Diseases Eye Diseases |