Congenital CataractNCT03610295
Prophylactic Peripheral Iridectomy Prevents Aphakic Angle-closure Glaucoma
A study testing PPI group and cataract extraction in people with Congenital Cataract and Aphakic Glaucoma, run by Zhongshan Ophthalmic Center, Sun Yat-sen University at 2 sites in China.
Trial summary
This is a retrospective, nonrandomized comparative trial with historical control to investigate the safety and efficacy of a novel progressive grasping peripheral iridectomy (PGPI) surgical method in preventing aphakic angle-closure glaucoma (AACG) following congenital cataract surgery. Read more about this study
- Who is it for?
- Ages 2 to 24 months
- Conditions the study is for
- Congenital Cataract, Aphakic Glaucoma
- What is being tested?
- PPI group and cataract extraction
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 87 participants
- Where
- 2 sitesChina
- Study dates
- 2 Aug 2018to 5 Mar 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 2 to 24 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- patients less than 2 years old;
- patients performed with congenital cataract surgery with or without PPI;
- patients with routine follow-up at ZOC.
Who cannot join
- patients with IOP ≥21 mm Hg or with congenital glaucoma or with a family history of glaucoma;
- patients with keratopathy, retinopathy, ocular trauma, radiation therapy or intraocular surgery;
- patients associated with other congenital ocular anomalies, such as anterior segment dysgenesis, microcornea/microphthalmia, persistent fetal vasculature, lens dislocation and iridocoloboma;
- patients with systemic diseases, such as Down's syndrome, Lowe syndrome, Stickler syndrome, maternal rubella syndrome or trisomy 13.
Trial locations and contacts
2 sites in 1 country.
China2 sites
State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Center, Sun Yat-sen University
Guangzhou, Guangdong, 510060
Zhongshan Ophthalmic Center, Sun Yet-san University
Guangzhou, Guangdong, 510060
About this study
Official title: A Novel Prophylactic Peripheral Iridectomy Prevents Aphakic Angle-closure Glaucoma After Congenital Cataract Surgery
This is a retrospective, nonrandomized comparative trial with historical control to investigate the safety and efficacy of a novel progressive grasping peripheral iridectomy (PGPI) surgical method in preventing aphakic angle-closure glaucoma (AACG) following congenital cataract surgery.
Read the detailed description
Aphakic angle-closure glaucoma (AACG) following congenital cataract surgery is a common and serious complication which can be prevented by prophylactic peripheral iridectomy (PPI). However, it is difficult to perform routine PPI via scleral tunnel incision especially when the pupil is dilated. Here, the investigators designed a novel progressive grasping peripheral iridectomy (PGPI) surgical method which can ensure the accurate iridectomy position and minimize the complication. The aim of this study is to assess the safety and efficacy of the PGPI in preventing AACG following congenital cataract surgery.
This is a retrospective, nonrandomized comparative trial with historical control. The congenital cataract patients performed with cataract extraction combined with PPI (PPI group) and the patients performed with cataract extraction alone and leaving the iris intact (historical control group) were enrolled and a retrospective medical chart review was conducted. The IOP, anterior chamber depth, corneal clarity, patency of peripheral iridectomy opening, and the rate of AACG, iris posterior synechia (IPS) and visual axis opacity (VAO) were compared between two groups.
- Conditions
- Congenital Cataract, Aphakic Glaucoma
- Being tested
- PPI group, cataract extraction
- Keywords
- congenital cataract, prophylactic peripheral iridectomy, aphakic angle-closure glaucoma, aphakic open-angle glaucoma, iris posterior synechia, visual axis opacity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PPI groupProcedure or surgery
The patients underwent cataract extraction, posterior capsulotomy, anterior vitrectomy combined with prophylactic peripheral iridectomy.
cataract extractionProcedure or surgery
The patients underwent cataract extraction, posterior capsulotomy combined with anterior vitrectomy and leave the iris intact.
| Study group | Role | What they receive |
|---|---|---|
| PPI group | Experimental | cataract extraction surgery with prophylactic peripheral iridectomy Receives: Procedure: PPI group |
| historical control group | Active comparator | cataract extraction surgery Receives: Procedure: cataract extraction |
What is being measured
The primary outcome is the main question the study is designed to answer.
The rate of aphakic angle-closure glaucoma
Pupillary block with subsequent closure of the filtration angle is the cause of early aphakic angle-closure glaucoma (AACG), which usually happens in the early postoperative period, generally within the first 6 months. AACG presents with elevated IOP (repeatedly >25 mmHg), corneal edema, iris bombe, shallow anterior chamber, peripheral anterior synechia and angle closure.
Measured: 18-49 months
Secondary outcomes (2)
The rate of iris posterior synechia
Postoperative uveal inflammation can result in iris posterior synechia (IPS), referring to the synechia between iris and capsule around pupil. IPS is graded according to the range of the synechia. Grade 0: no synechia; Grade I: <1 quadrant; Grade II: ≤2 quadrants and >1 quadrant ; Grade III: ≤3 quadrants and >2 quadrants; Grade IV: >3 quadrants.
Measured: 18-49 months
The rate of visual axis opacity
visual axis opacification (VAO) refers to developing reopacification of the visual axis in the form of lens proliferation into the visual axis or pupillary membrane.
Measured: 18-49 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2018
- Study start2 Aug 2018
- Primary completion5 Mar 2019
- Study completion5 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congenital CataractStudies 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
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Retrospective,consecutive,nonrandomized comparative trial with historical control
- Masking
- None (open label)
- Enrolment
- 87 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zhongshan Ophthalmic Center, Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yizhi Liu, Zhongshan Ophthalmic Center, Sun Yat-sen University
- Investigators
- Yizhi Liu, PhD, Principal investigator, Zhongshan Ophthalmic Center, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03610295
- Sponsor's protocol ID
- 2018KYPJ091
- Status last verified
- Mar 2019
- First submitted
- 25 Jul 2018
- Last updated
- 12 Mar 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Novel Prophylactic Peripheral Iridectomy Prevents Aphakic Angle-closure Glaucoma After Congenital Cataract Surgery
- ClinicalTrials.gov ID
- NCT03610295
- Acronym / sponsor ID
- 2018KYPJ091
- Conditions
- Congenital Cataract, Aphakic Glaucoma
- Keywords
- congenital cataract, prophylactic peripheral iridectomy, aphakic angle-closure glaucoma, aphakic open-angle glaucoma, iris posterior synechia, visual axis opacity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 87 participants (actual)
- Lead sponsor
- Zhongshan Ophthalmic Center, Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 2 Aug 2018 (actual)
- Primary completion
- 5 Mar 2019 (actual)
- Study completion
- 5 Mar 2019 (actual)
- First posted
- 1 Aug 2018 (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.
This is a retrospective, nonrandomized comparative trial with historical control to investigate the safety and efficacy of a novel progressive grasping peripheral iridectomy (PGPI) surgical method in preventing aphakic angle-closure glaucoma (AACG) following congenital cataract surgery.
Detailed description
Aphakic angle-closure glaucoma (AACG) following congenital cataract surgery is a common and serious complication which can be prevented by prophylactic peripheral iridectomy (PPI). However, it is difficult to perform routine PPI via scleral tunnel incision especially when the pupil is dilated. Here, the investigators designed a novel progressive grasping peripheral iridectomy (PGPI) surgical method which can ensure the accurate iridectomy position and minimize the complication. The aim of this study is to assess the safety and efficacy of the PGPI in preventing AACG following congenital cataract surgery.
This is a retrospective, nonrandomized comparative trial with historical control. The congenital cataract patients performed with cataract extraction combined with PPI (PPI group) and the patients performed with cataract extraction alone and leaving the iris intact (historical control group) were enrolled and a retrospective medical chart review was conducted. The IOP, anterior chamber depth, corneal clarity, patency of peripheral iridectomy opening, and the rate of AACG, iris posterior synechia (IPS) and visual axis opacity (VAO) were compared between two groups.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Retrospective,consecutive,nonrandomized comparative trial with historical control
| Arm | Type | Receives |
|---|---|---|
| PPI group | Experimental | Procedure: PPI groupcataract extraction surgery with prophylactic peripheral iridectomy |
| historical control group | Active comparator | Procedure: cataract extractioncataract extraction surgery |
Who may qualify
- Ages
- 2 to 24 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- patients less than 2 years old;
- patients performed with congenital cataract surgery with or without PPI;
- patients with routine follow-up at ZOC.
Key exclusion criteria (4 listed)
- patients with IOP ≥21 mm Hg or with congenital glaucoma or with a family history of glaucoma;
- patients with keratopathy, retinopathy, ocular trauma, radiation therapy or intraocular surgery;
- patients associated with other congenital ocular anomalies, such as anterior segment dysgenesis, microcornea/microphthalmia, persistent fetal vasculature, lens dislocation and iridocoloboma;
- patients with systemic diseases, such as Down's syndrome, Lowe syndrome, Stickler syndrome, maternal rubella syndrome or trisomy 13.
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 |
|---|---|---|
| PPI groupThe patients underwent cataract extraction, posterior capsulotomy, anterior vitrectomy combined with prophylactic peripheral iridectomy. | Procedure or surgery | PPI group |
| cataract extractionThe patients underwent cataract extraction, posterior capsulotomy combined with anterior vitrectomy and leave the iris intact. | Procedure or surgery | historical control group |
Primary outcome
The rate of aphakic angle-closure glaucoma
Time frame: 18-49 months
Pupillary block with subsequent closure of the filtration angle is the cause of early aphakic angle-closure glaucoma (AACG), which usually happens in the early postoperative period, generally within the first 6 months. AACG presents with elevated IOP (repeatedly >25 mmHg), corneal edema, iris bombe, shallow anterior chamber, peripheral anterior synechia and angle closure.
2 secondary outcomes
The rate of iris posterior synechia
Time frame: 18-49 months
The rate of visual axis opacity
Time frame: 18-49 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 12 Mar 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.
Yizhi Liu, PhD principal investigator
Zhongshan Ophthalmic Center, Sun Yat-sen University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PPI group and cataract extraction in people with Congenital Cataract and Aphakic Glaucoma, run by Zhongshan Ophthalmic Center, Sun Yat-sen University at 2 sites in China.
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 3 inclusion and 4 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 12 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. 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?
The rate of aphakic angle-closure glaucoma (time frame: 18-49 months). 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 12 Mar 2019.