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Effect of Cataract Surgery on Corneal Endothelium; About 2 TechniquesNCT05886283

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

A study testing phacoemulsification, utrasound phacoemulsification and nanolaser phacoemulsification in people with Effect of Cataract Surgery on Corneal Endothelium; About 2 Techniques, run by University Tunis El Manar at 1 site in Tunisia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 50 to 90 yearsHealthy volunteers can take part
What is being tested?
phacoemulsification, utrasound phacoemulsification and nanolaser phacoemulsification
Could I receive a placebo?
No, everyone receives an active treatment
How many people
74 participants
Where
1 siteTunisia
Study dates
1 Mar 2017to 30 Dec 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 to 90 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • -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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Tunisia1 site
  • Mohamed Taher Maamouri Hospital

    Nabeul, 8000

Other trials in Tunisia

About this study

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.

Read the detailed description

Methods:

A randomized prospective, uncontrolled cohort study was conducted at the Department of Ophthalmology of the Mohamed Taher Maamouri Hospital (MTMH) from March 2017 to May 2020. The MTMH ethics committee approved this study. All patients provided informed consent for the use of their data. The study adhered to all tenets of the declaration of Helsinki.

All patients underwent complete ocular examination including visual acuity, clinical corneal assessment, intraocular pressure (IOP) measurement, and nuclear hardness grading based on the lens opacity classification system III (LOCS III), commonly referred to in most studies. Only the nuclear component of the cataract (NO1 to NO4) was taken into account in the evaluation.

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

Patients were randomly divided into 2 groups. Group 1 had US PHACO using the phaco-chop technique (Stellaris PC: Bausch + Lomb®) and group 2 underwent an NL PHACO (Cetus A.R.C. Laser system®).

The Cetus A.R.C. Laser system is composed of a base that generates a 4 to 5 ns pulsed Nd: YAG of 1064 nm wavelength laser with a pulse frequency up to 10 Hz and an optic fiber that transmits the laser pulses to the disposable single-use coaxial handpiece. The probe used has a total diameter of 720 µm, occupied in its center by a 320 µm quartz optical fiber that transferred the laser pulse towards a titanium plate in the phaco probe. The individual pulse energy ranged from 30 to 50 % of maximum power and the pulse frequency was 1-2 Hz.

The base unit is connected to the same phaco aspiration/irrigation system and is controlled by the pedal of that system.

In both groups, surgery started with a clear corneal incision of 2.2 mm at 9 o'clock and a port incision of 1 to 1.5 mm at 2 o'clock using the same knife. Continuous Circular Capsulorhexis (CCC) of 6 mm was performed under the same ophthalmic viscosurgical device (3% Sodium hyaluronate, 4% chondroitin sulfate, DuoVisc® Alcon ). A hydro dissection was performed, then followed by phacoemulsification.

In-group 1 (horizontal phaco chop): after cortex aspiration, the nucleus was held with the phaco tip at a high vacuum. The phaco chopper was then introduced from the side port incision to engage, under the lower edge of CCC. It was then drawn towards the phaco tip to cleave it by a manual separation between the two instruments. The same process continued for the two nuclear halves and 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. Energy was expressed in % on the PHACO machine and initially converted into Watts according to the following curve "Figure 1" then into Joules based on the formula: Energy (Joules) = Power (Watts) × time (seconds).

In-group 2: The cortex and epinucleus were aspirated. 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. The energy used was calculated automatically by the ARC Laser machine and was displayed on the screen.

In both groups, after bimanual infusion/aspiration cortex removal and Visco expansion of the capsular bag, a hydrophobic single-piece: AcrySof acrylic (SA60AT, Alcon) IOL was implanted. The duration of the whole procedure (in minutes) was noted.

Uncorrected Visual acuity (UVA) at 1 day postoperative and BCVA at 1 week, 1, 3, 6, and 24 months after surgery as well as corneal edema and anterior chamber (AC ) reaction were recorded. A visual outcome of 0.5 logarithm of the minimal angle of resolution (logMar) without correction was considered a successful result based on the World Health Organization definition (1, 15, 16). The SM was performed at 1 week, 1, 3, 6, and 24 months after surgery. The investigators reported endothelial cell density (EDC) (cell/ mm²), the percentage of hexagonal cells, coefficient of variation (CoV) in cell size, and central corneal thickness (CCT) at each follow-up visit.

All the data were analyzed using SPSS software (version 21.0; SPSS, Inc., Chicago, IL, USA). BCVA data was converted into log MAR for statistical analyses. Quantitative variables were presented as medians, means, and standard deviations. The investigators used Student's t-test for the independent series. Pearson's correlation coefficient was used for searching the statistical relationship or association between variables. A p-value < 0.05 was accepted as statistically significant.

Being tested
phacoemulsification, utrasound phacoemulsification, nanolaser phacoemulsification
Keywords
cataract surgery, phacoemulsification, Nanosecond laser, endothelial cells density

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • phacoemulsificationProcedure or surgery

    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.

  • utrasound phacoemulsificationProcedure or surgery

    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

  • nanolaser phacoemulsificationProcedure or surgery

    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.

Study groups in NCT05886283
Study groupRoleWhat they receive
ultrasound phaco groupeActive comparatorthis group had US PHACO using the phaco-chop technique (Stellaris PC: Bausch + Lomb®)
Receives: Procedure: phacoemulsification; Procedure: utrasound phacoemulsification
nanolaser phaco groupActive comparatorthis group underwent an NL PHACO (Cetus A.R.C. Laser system®)
Receives: Procedure: phacoemulsification; Procedure: nanolaser phacoemulsification

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Endothelial cell density (ECD)

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

    Measured: 2 years

  2. Percentage of endothelial cell loss (ECL)

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

    Measured: 2 years

  3. Mean percentage of hexagonal cells

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

    Measured: 2 years

  4. Mean coefficient of variance (CoV)

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

    Measured: 2 years

  5. Central corneal thickness (CCT)

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

    Measured: 2 years

  6. Uncorrected visual acuity (UVA)

    UVA was evaluated at 1 day post-operatively

    Measured: 2 years

  7. Best corrected visual acuity (BCVA)

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Jun 2023
  2. Study start1 Mar 2017
  3. Primary completion31 May 2020
  4. Study completion30 Dec 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
A randomized prospective, uncontrolled cohort study
Masking
Single blind
Who is masked
Investigator
Enrolment
74 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05886283
Sponsor's protocol ID
14-03-2023
Status last verified
Jun 2023
First submitted
12 Apr 2023
Last updated
5 Jun 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 37809334

Questions about this trial

What is this clinical trial studying?

A study testing phacoemulsification, utrasound phacoemulsification and nanolaser phacoemulsification in people with Effect of Cataract Surgery on Corneal Endothelium; About 2 Techniques, run by University Tunis El Manar at 1 site in Tunisia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Tunisia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Endothelial cell density (ECD) (time frame: 2 years). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05886283, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2023.

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