ClinicalTrials.gg
Status unknownNCT05501535Updated Aug 17, 2022

Refraction Changes After Using ND: YAG LASER In Treatment of Posterior Capsular Opacification In Pseudo Phakic Eye

An observational study in Posterior Capsule Opacification, sponsored by Sohag University. Status unknown at 1 site in Egypt. Open to participants aged 40 Years to 70 Years. Per ClinicalTrials.gov, last updated 2022-08-17.

Sponsored by Sohag University · Observational

The sponsor has not verified this record recently (last verified Aug 2022), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
50
Ages
40 Years to 70 Years
Sex
All
01

Study 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 .

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

02

Conditions studied

  • Posterior Capsule Opacification

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03

In context

Capsule Opacification

28 studies on the registry are indexed under Capsule Opacification; 2 are open to participants now.

This study's planned enrollment of 50 is below the median of 200 across 11 observational studies indexed under Capsule Opacification.

Browse Capsule Opacification studies →

Lead sponsor

Sohag University is the lead sponsor of 1,230 studies on the registry; 636 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

sohag university hospital patients in ophthalmology clinc

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • presence of central Posterior capsular opacification

Exclusion criteria

Exclusion Criteria:

  • High Intra ocular pressure
  • Corneal opacities or dystrophies.
  • Dense posterior capsular opacification where no refraction could be obtained
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
50 participants (estimated)
Patient registry
No

Groups and cohorts

  • pseudophakic patients before and after having ND YAG laser

    Device: ND:YAG LASER

Interventions

  • DeviceND:YAG LASER

    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

06

What researchers measure

Primary outcomes

  1. objective refractive changes in sphere and cylinder refraction

    using autorefractometer

    Time frame: one month

07

Study locations

1 of 1 sites recruiting
  • Sohag university hospital
    Sohag, Egypt
    Recruiting
08

References and documents

Individual participant data

Plan to share: 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,

Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, Analytic code

Time frame: 6 months after publication

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Oct 2021 (actual). Primary completion is estimated for Oct 2022, 12 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 11, 2022
First posted
Aug 15, 2022
StartActual
Oct 1, 2021
Primary completionEst.
Oct 1, 2022
CompletionEst.
Nov 1, 2022
Last update
Aug 17, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 17, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05501535
Lead sponsor
Sohag University
Responsible party
Mohmamed Elsayed Mohamed Ahmed (Principal investigator, Sohag University) — Principal investigator
First posted
Aug 15, 2022
Start date
Oct 1, 2021
Primary completion
Oct 1, 2022 (estimated)
Completion
Nov 1, 2022 (estimated)
Last update
Aug 17, 2022

Study contacts

Mohamed ms elsayed, resident
Contact
drdocmohamed@gmail.com
00201142206869
mohamed elagouz, prof
study chair · unaffilatted

Oversight

FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Aug 2022. You cannot join it, but the record below documents what was studied.

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