Posterior Capsule OpacificationNCT05501535
Refraction Changes After Using ND: YAG LASER In Treatment of Posterior Capsular Opacification In Pseudo Phakic Eye
An observational study of Posterior Capsule Opacification, run by Sohag University at 1 site in Egypt.
Trial summary
The most prevalent long term consequence of cataract surgery in both phacoemulsification and extracapsular cataract excision is posterior capsular opacification (PCO) PCO occurred in 11.8 percent of patients one year after surgery, 20.7 percent in three years, and 28.4 percent in five years . Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Posterior Capsule Opacification
- What is being tested?
- ND:YAG LASER
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2021to 1 Nov 2022
- Phase
- Observational
- 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 40 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: sohag university hospital patients in ophthalmology clinc
Who may be able to join
- presence of clinically significant central Posterior capsular opacification
Who cannot join
- High Intra ocular pressure
- Corneal opacities or dystrophies.
- Dense posterior capsular opacification where no refraction could be obtained
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Sohag university hospital
Sohag
mohamed elsayed, resident, 00201142206869, drdocmohamed@gmail.com
About this study
Official title: Objective Refraction Changes After Using ND: YAG LASER In Treatment of Posterior Capsular Opacification In Pseudo Phakic Eye After Successful Non Complicated Cataract Surgery
The most prevalent long term consequence of cataract surgery in both phacoemulsification and extracapsular cataract excision is posterior capsular opacification (PCO) PCO occurred in 11.8 percent of patients one year after surgery, 20.7 percent in three years, and 28.4 percent in five years .
It causes lower visual acuity, decreased contrast sensitivity, stereoscopic vision, increases glare and monocular diplopia. The pathogenesis of PCO is dependent on the growth of lens epithelial cell remnants in the intracapsular region. Continuous curvilinear capsulorhexis, good hydro dissection, efficient removal of cortical and lenticular epithelial cells, in-the-bag IOL implantation, and the use of single-piece acrylic sharp edges IOLs are all factors in PCO avoidance. Intraoperatively, anti-metabolites such as 5-fluorouracil and mitomycin C may also be utilized.
Read more
Fortunately, the overall prevalence of PCO and the using of neodymium-yttrium-aluminum-garnet (Nd: YAG) laser posterior Capsulotomy rates have dropped from 50% to fewer than 10% now The standard therapy for PCO is now Nd: YAG laser posterior capsulotomy, which has a success rate of more than 95%. The neodymium: yttrium-aluminum-garnet (Nd:YAG) laser, with a wavelength of 1064 nm, is a solid-state laser that may destroy ocular tissues by achieving optical breakdown with a brief, high-power pulse .Ionization or plasma production occurs in the ocular tissue as a result of optical breakdown. This plasma production subsequently generates acoustic and shock waves, which destroy tissue. Because of its cost-effectiveness, speed, and lack of invasiveness, it is the chosen treatment option in PCO.
However laser capsulotomy is not free of complications including transient intraocular pressure (IOP) elevation, hyphema, uveitis, cystoid macular edema, and retinal detachments that occur most frequently in the first few months . Apart from the afore mentioned biological complications, mechanical effects of laser capsulotomy such as pitting of IOL, dislocation of IOL into the vitreous, and shift in the position of IOL have also be reported Displacement of the IOL following laser capsulotomy, which may be impacted by the capsulotomy size , might hypothetically modify the effective power of the IOL as well as the patients' refractive state may be altered . However, with the exception of one research that demonstrated a hyperopic shift after Nd:YAG laser capsulotomy , most prior investigations failed to show a significant change in refraction before and after Nd:YAG laser capsulotomy . According to earlier study , the size and form of Nd:YAG laser capsulotomy, the energy utilized in Nd:YAG laser capsulotomy, and the designs of IOL did not alter the post-laser refractive state.
It is still unknown if the time of laser capsulotomy affects the refractive and visual prognosis of patients after Nd:YAG laser capsulotomy. Because the IOL would continue to rotate for at least 6 months following cataract surgery, Any considerable change in IOL position might result in a change in the patient's refractive state, necessitating corrective lens prescriptions
- Conditions
- Posterior Capsule Opacification
- Being tested
- ND:YAG LASER
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ND:YAG LASERDevice
The standard therapy for PCO is now Nd: YAG laser posterior capsulotomy, which has a success rate of more than 95%. The neodymium: yttrium-aluminum-garnet (Nd:YAG) laser, with a wavelength of 1064 nm, is a solid-state laser that may destroy ocular tissues by achieving optical breakdown with a brief, high-power pulse .Ionization or plasma production occurs in the ocular tissue as a result of optical breakdown. This plasma production subsequently generates acoustic and shock waves, which destroy tissue. Because of its cost-effectiveness, speed, and lack of invasiveness, it is the chosen treatment option in PCO
| Study group | Role | What they receive |
|---|---|---|
| pseudophakic patients before and after having ND YAG laser | Not described Receives: Device: ND:YAG LASER |
What is being measured
The primary outcome is the main question the study is designed to answer.
objective refractive changes in sphere and cylinder refraction
using autorefractometer
Measured: one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2022
- Study start1 Oct 2021
- Primary completion1 Oct 2022 (estimated)
- Study completion1 Nov 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Posterior Capsule OpacificationStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohmamed Elsayed Mohamed Ahmed, Sohag University
- Investigators
- mohamed elagouz, prof, Study chair, unaffilatted
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05501535
- Sponsor's protocol ID
- Soh-Med-22-08-05
- Status last verified
- Aug 2022
- First submitted
- 11 Aug 2022
- Last updated
- 17 Aug 2022
- Results posted
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: All patients will be evaluated eventually one month after the procedure which included BCVA and slit lamp examination. Patients undergo retinoscopy and auto-refractometer . Then subjective refraction will be performed and readings will be documented. The changes in refraction will be noted and analyzed. Spherical and cylindrical error shift post procedure will be determined The collected data will be tabulated, coded and analyzed using SPSS program,
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Objective Refraction Changes After Using ND: YAG LASER In Treatment of Posterior Capsular Opacification In Pseudo Phakic Eye After Successful Non Complicated Cataract Surgery
- ClinicalTrials.gov ID
- NCT05501535
- Acronym / sponsor ID
- Soh-Med-22-08-05
- Conditions
- Posterior Capsule Opacification
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 1 Oct 2022 (estimated)
- Study completion
- 1 Nov 2022 (estimated)
- First posted
- 15 Aug 2022 (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.
The most prevalent long term consequence of cataract surgery in both phacoemulsification and extracapsular cataract excision is posterior capsular opacification (PCO) PCO occurred in 11.8 percent of patients one year after surgery, 20.7 percent in three years, and 28.4 percent in five years .
It causes lower visual acuity, decreased contrast sensitivity, stereoscopic vision, increases glare and monocular diplopia. The pathogenesis of PCO is dependent on the growth of lens epithelial cell remnants in the intracapsular region. Continuous curvilinear capsulorhexis, good hydro dissection, efficient removal of cortical and lenticular epithelial cells, in-the-bag IOL implantation, and the use of single-piece acrylic sharp edges IOLs are all factors in PCO avoidance. Intraoperatively, anti-metabolites such as 5-fluorouracil and mitomycin C may also be utilized.
Fortunately, the overall prevalence of PCO and the using of neodymium-yttrium-aluminum-garnet (Nd: YAG) laser posterior Capsulotomy rates have dropped from 50% to fewer than 10% now The standard therapy for PCO is now Nd: YAG laser posterior capsulotomy, which has a success rate of more than 95%. The neodymium: yttrium-aluminum-garnet (Nd:YAG) laser, with a wavelength of 1064 nm, is a solid-state laser that may destroy ocular tissues by achieving optical breakdown with a brief, high-power pulse .Ionization or plasma production occurs in the ocular tissue as a result of optical breakdown. This plasma production subsequently generates acoustic and shock waves, which destroy tissue. Because of its cost-effectiveness, speed, and lack of invasiveness, it is the chosen treatment option in PCO.
However laser capsulotomy is not free of complications including transient intraocular pressure (IOP) elevation, hyphema, uveitis, cystoid macular edema, and retinal detachments that occur most frequently in the first few months . Apart from the afore mentioned biological complications, mechanical effects of laser capsulotomy such as pitting of IOL, dislocation of IOL into the vitreous, and shift in the position of IOL have also be reported Displacement of the IOL following laser capsulotomy, which may be impacted by the capsulotomy size , might hypothetically modify the effective power of the IOL as well as the patients' refractive state may be altered . However, with the exception of one research that demonstrated a hyperopic shift after Nd:YAG laser capsulotomy , most prior investigations failed to show a significant change in refraction before and after Nd:YAG laser capsulotomy . According to earlier study , the size and form of Nd:YAG laser capsulotomy, the energy utilized in Nd:YAG laser capsulotomy, and the designs of IOL did not alter the post-laser refractive state.
It is still unknown if the time of laser capsulotomy affects the refractive and visual prognosis of patients after Nd:YAG laser capsulotomy. Because the IOL would continue to rotate for at least 6 months following cataract surgery, Any considerable change in IOL position might result in a change in the patient's refractive state, necessitating corrective lens prescriptions
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| pseudophakic patients before and after having ND YAG laser | – | Device: ND:YAG LASER |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- sohag university hospital patients in ophthalmology clinc
Key inclusion criteria (1 listed)
- presence of clinically significant central Posterior capsular opacification
Key exclusion criteria (3 listed)
- High Intra ocular pressure
- Corneal opacities or dystrophies.
- Dense posterior capsular opacification where no refraction could be obtained
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 |
|---|---|---|
| ND:YAG LASERThe standard therapy for PCO is now Nd: YAG laser posterior capsulotomy, which has a success rate of more than 95%. The neodymium: yttrium-aluminum-garnet (Nd:YAG) laser, with a wavelength of 1064 nm, is a solid-state laser that may destroy ocular tissues by achieving optical breakdown with a brief, high-power pulse .Ionization or plasma production occurs in the ocular tissue as a result of optical breakdown. This plasma production subsequently generates acoustic and shock waves, which destroy tissue. Because of its cost-effectiveness, speed, and lack of invasiveness, it is the chosen treatment option in PCO | Device | pseudophakic patients before and after having ND YAG laser |
Primary outcome
objective refractive changes in sphere and cylinder refraction
Time frame: one month
using autorefractometer
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2022.
- Individual participant dataSharing planned: Yes. All patients will be evaluated eventually one month after the procedure which included BCVA and slit lamp examination. Patients undergo retinoscopy and auto-refractometer . Then subjective refraction will be performed and readings will be documented. The changes in refraction will be noted and analyzed. Spherical and cylindrical error shift post procedure will be determined The collected data will be tabulated, coded and analyzed using SPSS program,
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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.
mohamed elagouz, prof study chair
unaffilatted
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Posterior Capsule Opacification, run by Sohag University at 1 site in Egypt.
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 1 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 17 Aug 2022. 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 Egypt. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mohamed ms elsayed, resident (00201142206869, drdocmohamed@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
objective refractive changes in sphere and cylinder refraction (time frame: one month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Aug 2022; AzTrials last refreshed its copy on 26 Oct 2026.