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.
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
- Conditions the study is for
- Effect of Cataract Surgery on Corneal Endothelium; About 2 Techniques
- What is being tested?
- phacoemulsification, utrasound phacoemulsification and nanolaser phacoemulsification
- Type of treatment
- Injection or infusion, Surgery or procedure
- 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.
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 group | Role | What they receive |
|---|---|---|
| ultrasound phaco groupe | Active comparator | this group had US PHACO using the phaco-chop technique (Stellaris PC: Bausch + Lomb®) Receives: Procedure: phacoemulsification; Procedure: utrasound phacoemulsification |
| nanolaser phaco group | Active comparator | this 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.
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
Percentage of endothelial cell loss (ECL)
ECL was evaluated using a non-contact specular microscope (SM) (TOMEY CORP EM-4000).
Measured: 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).
Measured: 2 years
Mean coefficient of variance (CoV)
CoV was evaluated using a non-contact specular microscope (SM) (TOMEY CORP EM-4000).
Measured: 2 years
Central corneal thickness (CCT)
CCT was evaluated using a non-contact specular microscope (SM) (TOMEY CORP EM-4000).
Measured: 2 years
Uncorrected visual acuity (UVA)
UVA was evaluated at 1 day post-operatively
Measured: 2 years
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.
- First posted2 Jun 2023
- Study start1 Mar 2017
- Primary completion31 May 2020
- Study completion30 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Effect of Cataract Surgery on Corneal Endothelium; About 2 TechniquesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- University Tunis El Manar
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Walid Zbiba, University Tunis El Manar
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
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Qualitative and Quantitative Endothelium Changes After Cataract Surgery: Ultrasound Phacoemulsification vs Nanolaser Technique
- ClinicalTrials.gov ID
- NCT05886283
- Acronym / sponsor ID
- 14-03-2023
- Keywords
- cataract surgery, phacoemulsification, Nanosecond laser, endothelial cells density
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- University Tunis El ManarUniversity, hospital or other
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- 31 May 2020 (actual)
- Study completion
- 30 Dec 2020 (actual)
- First posted
- 2 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- A randomized prospective, uncontrolled cohort study
| Arm | Type | Receives |
|---|---|---|
| ultrasound phaco groupe | Active comparator | Procedure: phacoemulsification, Procedure: utrasound phacoemulsificationthis group had US PHACO using the phaco-chop technique (Stellaris PC: Bausch + Lomb®) |
| nanolaser phaco group | Active comparator | Procedure: phacoemulsification, Procedure: nanolaser phacoemulsificationthis group underwent an NL PHACO (Cetus A.R.C. Laser system®) |
Who may qualify
- Ages
- 50 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- -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
Key exclusion criteria (2 listed)
- Conversion from NL PHACO to US PHACO.
- Surgery was complicated with capsular rent and vitreous loss.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| phacoemulsificationwe 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 or surgery | nanolaser phaco group, ultrasound phaco groupe |
| utrasound phacoemulsificationUS 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 | Procedure or surgery | ultrasound phaco groupe |
| nanolaser phacoemulsificationLaser 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. | Procedure or surgery | nanolaser phaco group |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2023.
- Derived from this study: PubMed 37809334Zbiba 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.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
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.