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Posterior Capsule OpacificationPCONCT04007965

Novel Technique of Pneumatic Posterior Capsulorhexis for Treatment and Prevention of Posterior Capsular Opacification

A study testing Pneumatic Posterior Capsulorhexis in people with Posterior Capsule Opacification, run by Minia University at 1 site in Saudi Arabia.

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

ABSTRACT PURPOSE: To evaluate a new technique of posterior capsulorhexis using air support to treat primary posterior capsular opacification (PCO) during cataract extraction surgery or to prevent post-operative PCO. SETTING: 1-Ophthalmology department, Faculty of medicine, Minia University, El-Minia, Egypt. Read more about this study

Who is it for?
Ages 50 to 73 yearsHealthy volunteers can take part
Conditions the study is for
Posterior Capsule Opacification
What is being tested?
Pneumatic Posterior Capsulorhexis
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
1 siteSaudi Arabia
Study dates
1 Jan 2017to 25 Jun 2019
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 73 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Dense mature cataract without any local or systemic causes for the cataract.

Who cannot join

  • Any patients did not complete the follow up visits
  • younger patients and children

Trial locations and contacts

1 site in 1 country.

Saudi Arabia1 site
  • Security forces hospital

    Riyadh, Central, 11481-3643

Other trials in Saudi Arabia

About this study

ABSTRACT PURPOSE: To evaluate a new technique of posterior capsulorhexis using air support to treat primary posterior capsular opacification (PCO) during cataract extraction surgery or to prevent post-operative PCO.

SETTING: 1-Ophthalmology department, Faculty of medicine, Minia University, El-Minia, Egypt.

Read more

2- Security Forces Hospital, Ophthalmology Department, Riyadh, Kingdom of Saudi Arabia.

DESIGN: Prospective, randomized case-control comparative study.

Methods: 100 eyes of 100 patients with a mean age of 63.3 years with dens cataract. Fifty of them ( group 1) with primary PCO (discovered during the operations) and fifty (group 2) with clear posterior capsule.

All cases undergone phacoemulsification, posterior capsulorhexis using the air to support the posterior capsule and separate it from the vitreous (the novel technique will be discussed later). Then IOL implantations wear done in the bag between the anterior and posterior capsular rim. Each patient was evaluated for the following:- visual acuity (UCVA and BCVA), intraocular pressure, intra ocular lens stability, visual axis opacification and posterior segment complications as retinal break, retinal detachment or cystoid macular oedema.

Read the detailed description

Introduction. Posterior capsular opacification (PCO) is one of the common late post-operative complications of phacoemulsification and ECCE. The treatment of PCO by YAG laser capsulotomy usually leads to the famous annoying symptom (musca) and carries the risk of IOP elevation. Moreover, it may lead to the posterior segment complications ( cystoid macular edema, retinal breaks and detachment). There is no reliable treatment for prevention of PCO.

The current available modalities to prevent postoperative PCO are:

  • Some surgical modifications as hydrodissection, repeated nucleus rotation and meticulous polishing of the lens epithelial cells (LECs) from anterior capsular rim and equator. In 1989 David Apple and his group (1) had demonstrated the value of hydrodissection. In 1992, they further emphasized hydrodissection as well as barriers to migration of equatorial cells to the posterior capsule as methods which could reduce PCO (2). In the same year Fine described a technique which he termed 'cortical cleaving hydrodissection', (3) which was designed to break the equatorial adhesions between lens epithelial cells and the capsule, thus increasing the chance of significant clearance of these cells which are the progenitors of PCO. In 2006 they pointed out to the laboratory and clinical evidence that good hydrodissection, coupled with mechanical 'scouring' of LECs from the equator may have beneficial effect on decreasing PCO incidence. (4,5). In a laboratory experiment they found that there were significantly fewer cells remaining in the capsule equator in the group of eyes where the lens had been rotated three times within the bag prior to removal, compared with no such rotation(4).
  • Changes in the IOL design and materials: e.g. The square edge of the optic and acrylic IOL decreases the incidence of postoperative PCO than with PMMA IOLs of similar design.
  • Pharmacological strategies either to kill the residual epithelial cells or to prevent their post operative proliferation. The pharmacological prevention has been largely unsuccessful so far. Moreover, any agent must be toxic to these epithelial cells without being toxic to the corneal endothelium. Few agents have been partially successful without clinical application till now (6).

The incidence of PCO following successful cataract surgery has been falling since the general acceptance of posterior chamber in-the-bag intraocular lens (IOL) implantation. Improvement in lens materials, lens design and technique are well documented to decrease the incidence of postoperative PCO (8, 9). Rotation three times of the hydrodissected nucleus prior to phacoemulsification and a second hydrodissection after nucleus removal are simple and safe maneuvers that statistically improve the results (9). Bimanual irrigation/aspiration may also help.(10) Treatment options for PCO

  • YAG laser posterior capsulotomy
  • Surgical posterior capsulotomy or capsulectomy
  • Primary (Intra-operative)
  • Secondary.

Patients and methods:

Indications of the new technique

  1. Intraoperative PCO in white cataract.
  2. As a primary procedure during cataract extraction to prevent post-operative PCO. Thirty eyes of 100 patients with dens cataract were chosen from the outpatient clinic of the ophthalmology department, Minia University Hospital, El-Minia Egypt. The patient's age ranged from 50-73 years with a mean age of 63.3 years 50 males and 50 females without any local or systemic causes for the cataract. The study group included fifty eyes (group1) with PCO, and fifty eyes (group 2) with clear posterior capsule (discovered intra-operative). All cases were subjected to complete ophthalmic examinations and echographic data registration. All cases undergone Phacoemulsification, posterior capsulorhexis using the air to support the posterior capsule and separate it from the vitreous face. Table (1)

The novel technique:

After complete phacoemulsification of the nucleus and I/A:

  1. Visco-elastic material was injected to make the anterior chamber formed without deepening so that the posterior capsule is not forcibly pushed backward.
  2. The posterior capsule punctured centrally using cysteotome Fig. (1).
  3. Controllable one shot injection of 0.1 ml of sterile air through the posterior capsule puncture which elevate, support and separate the posterior capsule from vitreous face. (Insulin syringe and Helon cannula were used) Fig. (2).
  4. Another visco-elastic injection to the anterior chamber to stretch the posterior capsule and sandwitich it between visco-elastic above and the air below Fig. (3).
  5. Posterior capsulorhexis 4-5 mm is now performed easily using capsulorhexis forceps then foldable IOL was implanted between the anterior and posterior capsular rim .
Being tested
Pneumatic Posterior Capsulorhexis
Keywords
PCO

What participants receive

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

  • Pneumatic Posterior CapsulorhexisProcedure or surgery

    Pneumatic Posterior Capsulorhexis using air dose 0.1 ml and Healon dose 0.5 -1.0 ml.

Study groups in NCT04007965
Study groupRoleWhat they receive
Opacified posterior capsuleExperimentalPCO
Receives: Procedure: Pneumatic Posterior Capsulorhexis
Clear posterior capsuleActive comparatorCPC
Receives: Procedure: Pneumatic Posterior Capsulorhexis

What is being measured

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

  1. Visual acuity measured using snellen chart projector

    visual acuity (UCVA and BCVA) measured in decimal values

    Measured: one year

  2. IOP measured in numerical values

    Intra-ocular pressure measured by Tono pen

    Measured: one year

  3. IOL stability

    Intraocular Lens stability seen by slit lamb examination

    Measured: one year

  4. Visual Axis Opacification

    Visual Axis Opacification seen by slit lamb examination

    Measured: 0ne year

Secondary outcomes (1)
  1. posterior segment complications

    posterior segment complications as retinal break, retinal detachment or cystoid macular oedema.

    Measured: 18 months

Timeline

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

  1. First posted5 Jul 2019
  2. Study start1 Jan 2017
  3. Primary completion31 Jan 2018
  4. Study completion25 Jun 2019

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
Masking
None (open label)
Enrolment
100 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04007965
Sponsor's protocol ID
Minia University
Acronym
PCO
Status last verified
Jul 2019
First submitted
29 Jun 2019
Last updated
5 Jul 2019
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Walker TD. Pharmacological attempts to reduce posterior capsule opacification after cataract surgery--a review. Clin Exp Ophthalmol. 2008 Dec;36(9):883-90. doi: 10.1111/j.1442-9071.2009.01921.x.

    PubMed 19278485
  • Eid AM, Abd-Elhamid Mehany Elwan S, Sabry AM, Moharram HM, Bakhsh AM. Novel Technique of Pneumatic Posterior Capsulorhexis for Treatment and Prevention of Posterior Capsular Opacification. J Ophthalmol. 2019 Dec 21;2019:3174709. doi: 10.1155/2019/3174709. eCollection 2019.

    PubMed 31949950

Questions about this trial

What is this clinical trial studying?

A study testing Pneumatic Posterior Capsulorhexis in people with Posterior Capsule Opacification, run by Minia University at 1 site in Saudi Arabia.

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 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 Jul 2019. 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 Saudi Arabia. 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?

Visual acuity measured using snellen chart projector (time frame: one year). The study lists 4 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 NCT04007965, which also lists 2 linked publications.

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 Jul 2019; AzTrials last refreshed its copy on 8 Nov 2026.

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