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.
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.
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
- Intraoperative PCO in white cataract.
- 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:
- Visco-elastic material was injected to make the anterior chamber formed without deepening so that the posterior capsule is not forcibly pushed backward.
- The posterior capsule punctured centrally using cysteotome Fig. (1).
- 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).
- 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).
- Posterior capsulorhexis 4-5 mm is now performed easily using capsulorhexis forceps then foldable IOL was implanted between the anterior and posterior capsular rim .
- Conditions
- Posterior Capsule Opacification
- 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 group | Role | What they receive |
|---|---|---|
| Opacified posterior capsule | Experimental | PCO Receives: Procedure: Pneumatic Posterior Capsulorhexis |
| Clear posterior capsule | Active comparator | CPC Receives: Procedure: Pneumatic Posterior Capsulorhexis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual acuity measured using snellen chart projector
visual acuity (UCVA and BCVA) measured in decimal values
Measured: one year
IOP measured in numerical values
Intra-ocular pressure measured by Tono pen
Measured: one year
IOL stability
Intraocular Lens stability seen by slit lamb examination
Measured: one year
Visual Axis Opacification
Visual Axis Opacification seen by slit lamb examination
Measured: 0ne year
Secondary outcomes (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.
- First posted5 Jul 2019
- Study start1 Jan 2017
- Primary completion31 Jan 2018
- Study completion25 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Posterior Capsule OpacificationStudies of the same condition, open and under way.
- More trials run by Minia UniversityThe sponsor's other registered studies.
- 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
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Minia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shaaban Elwan, Minia University
- Investigators
- Ahmed M Eid, MD, Study chair, Minia University
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 19278485Eid 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
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Novel Technique of Pneumatic Posterior Capsulorhexis for Treatment and Prevention of Posterior Capsular Opacification
- ClinicalTrials.gov ID
- NCT04007965
- Acronym / sponsor ID
- PCO / Minia University
- Conditions
- Posterior Capsule Opacification
- Keywords
- PCO
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Minia UniversityUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 31 Jan 2018 (actual)
- Study completion
- 25 Jun 2019 (actual)
- First posted
- 5 Jul 2019 (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.
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.
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.
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
- Intraoperative PCO in white cataract.
- 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:
- Visco-elastic material was injected to make the anterior chamber formed without deepening so that the posterior capsule is not forcibly pushed backward.
- The posterior capsule punctured centrally using cysteotome Fig. (1).
- 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).
- 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).
- Posterior capsulorhexis 4-5 mm is now performed easily using capsulorhexis forceps then foldable IOL was implanted between the anterior and posterior capsular rim .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Opacified posterior capsule | Experimental | Procedure: Pneumatic Posterior CapsulorhexisPCO |
| Clear posterior capsule | Active comparator | Procedure: Pneumatic Posterior CapsulorhexisCPC |
Who may qualify
- Ages
- 50 to 73 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Dense mature cataract without any local or systemic causes for the cataract.
Key exclusion criteria (2 listed)
- Any patients did not complete the follow up visits
- younger patients and children
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 |
|---|---|---|
| Pneumatic Posterior CapsulorhexisPneumatic Posterior Capsulorhexis using air dose 0.1 ml and Healon dose 0.5 -1.0 ml. | Procedure or surgery | Clear posterior capsule, Opacified posterior capsule |
Primary outcome
Visual acuity measured using snellen chart projector
Time frame: one year
visual acuity (UCVA and BCVA) measured in decimal values
IOP measured in numerical values
Time frame: one year
Intra-ocular pressure measured by Tono pen
IOL stability
Time frame: one year
Intraocular Lens stability seen by slit lamb examination
Visual Axis Opacification
Time frame: 0ne year
Visual Axis Opacification seen by slit lamb examination
1 secondary outcome
posterior segment complications
Time frame: 18 months
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 Jul 2019.
- Background: PubMed 19278485Walker 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.
- Derived from this study: PubMed 31949950Eid 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.
- Individual participant dataSharing planned: No
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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.
Ahmed M Eid, MD study chair
Minia University
1 site in 1 country: see every site and its status.
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.