Lens Implantation, IntraocularNCT05136950
Incidence of Glaucoma-related Adverse Events in Pediatric Secondary Intraocular Lens Implantation
A study testing Secondary in-the-bag IOL fixation and Secondary ciliary sulcus IOL fixation in people with Lens Implantation, Intraocular, run by Zhongshan Ophthalmic Center, Sun Yat-sen University at 1 site in China.
Trial summary
To compare the incidence of glaucoma-related adverse events of in-the-bag versus ciliary-sulcus-fixed secondary intraocular lens (IOL) implantation in pediatric aphakia Read more about this study
- Who is it for?
- Ages 18 months to 14 years
- Conditions the study is for
- Lens Implantation, Intraocular
- What is being tested?
- Secondary in-the-bag IOL fixation and Secondary ciliary sulcus IOL fixation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 228 participants
- Where
- 1 siteChina
- Study dates
- 14 Dec 2021to 30 Jul 2033
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 months to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Aged between 18 months and 14 years
- Had a primary diagnosis of congenital cataract.
- Underwent cataract extraction between the ages of 2 and 24 months
Who cannot join
- Primary IOL implantation
- Pre-existing ocular disease which might affect the location and outcome of secondary IOL implantation (including and not restricted to microphthalmia, microcornea, microcornea, corneal opacity, pseudopterygium, iris anomaly, glaucoma diagnosed before cataract extraction, uveitis, persistent fetal vasculature or trauma)
- Suture fixation for secondary IOL implantation
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Zhongshan Ophthalmic Center, Sun Yat-sen University Guangzhou, China, 510060
Guangzhou, 510060
Zhenzhen Liu, PhD, +8613570382241, liu_zhenzhen@qq.com
About this study
Official title: Incidence of Glaucoma-related Adverse Events in Pediatric Secondary Intraocular Lens Implantation, In-the-bag Versus Sulcus Fixation : a Randomized Controlled Trial
To compare the incidence of glaucoma-related adverse events of in-the-bag versus ciliary-sulcus-fixed secondary intraocular lens (IOL) implantation in pediatric aphakia
Read the detailed description
Treatment of pediatric cataract, one of the leading causes of childhood blindness globally, remains challenging because of extremely high incidence of glaucoma-related adverse events (AEs) after IOL implantation. The investigators aim to compare the incidence of glaucoma-related AEs of in-the-bag versus ciliary-sulcus-fixed secondary intraocular lens (IOL) implantation in pediatric aphakia.
- Conditions
- Lens Implantation, Intraocular
- Being tested
- Secondary in-the-bag IOL fixation, Secondary ciliary sulcus IOL fixation
- Keywords
- Pediatric aphakia, Secondary Intraocular Lens Implantation, Glaucoma-related Adverse Events, In-the-bag IOL implantation, Sulcus IOL fixation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Secondary in-the-bag IOL fixationProcedure or surgery
The experimental group with secondary IOL fixated in the capsular bag
Secondary ciliary sulcus IOL fixationProcedure or surgery
The control group with secondary IOL fixated in the ciliary sulcus
| Study group | Role | What they receive |
|---|---|---|
| Secondary in-the-bag IOL fixation group | Experimental | In-the-bag IOL fixation is the experimental arm Receives: Procedure: Secondary in-the-bag IOL fixation |
| Secondary ciliary sulcus IOL fixation group | Active comparator | Ciliary sulcus IOL fixation is the control arm Receives: Procedure: Secondary ciliary sulcus IOL fixation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of glaucoma-related adverse events
The assessment of glaucoma-related adverse events is performed at one year after surgery
Measured: One year after surgery
Secondary outcomes (6)
Incidence of glaucoma-related adverse events
The assessment of glaucoma-related AEs is performed at six months, three years, five years, ten years after surgery
Measured: Six months,three years, five years, ten years after surgery
Visual acuity
Evaluated with an ETDRS chart. For those who are unable to use ETDRS chart, visual acuity will be evaluated with Lea Symbol Chart or Teller Acuity Cards
Measured: Six months,one year, three years, five years, ten years after surgery
Ocular refractive power
Measured by the Auto Refractometer
Measured: Six months,one year,three years, five years, ten years after surgery
Intraocular lens decentration
Measured by anterior segment scanning
Measured: Six months,one year, three years, five years, ten years after surgery
Intraocular lens tilt
Measured by anterior segment scanning
Measured: Six months,one year, three years, five years, ten years after surgery
Incidence of other adverse events
The assessment of other adverse events will be performed at six months,one year,three years, five years, ten years after surgery
Measured: Six months,one year, three years, five years, ten years after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2021
- Study start14 Dec 2021
- Primary completion30 Jul 2023 (estimated)
- Study completion30 Jul 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Lens Implantation, IntraocularStudies of the same condition, open and under way.
- More trials run by Zhongshan Ophthalmic Center, Sun Yat-sen 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 228 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yizhi Liu, PhD, Principal investigator, Zhongshan Ophthalmic center, Guangzhou, People's Republic of China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05136950
- Sponsor's protocol ID
- 2021KYPJ135
- Status last verified
- Jan 2022
- First submitted
- 1 Nov 2021
- Last updated
- 11 Jan 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Liu Z, Lin H, Jin G, Tan X, Qu B, Jin L, Chen X, Wang W, Han X, Xu J, Ying G, Han Y, He M, Congdon N, Chen W, Luo L, Liu Y. In-the-Bag Versus Ciliary Sulcus Secondary Intraocular Lens Implantation for Pediatric Aphakia: A Prospective Comparative Study. Am J Ophthalmol. 2022 Apr;236:183-192. doi: 10.1016/j.ajo.2021.10.006. Epub 2021 Oct 13.
PubMed 34653355Wood KS, Tadros D, Trivedi RH, Wilson ME. Secondary intraocular lens implantation following infantile cataract surgery: intraoperative indications, postoperative outcomes. Eye (Lond). 2016 Sep;30(9):1182-6. doi: 10.1038/eye.2016.131. Epub 2016 Jul 1.
PubMed 27367747Freedman SF, Beck AD, Nizam A, Vanderveen DK, Plager DA, Morrison DG, Drews-Botsch CD, Lambert SR; Infant Aphakia Treatment Study Group. Glaucoma-Related Adverse Events at 10 Years in the Infant Aphakia Treatment Study: A Secondary Analysis of a Randomized Clinical Trial. JAMA Ophthalmol. 2021 Feb 1;139(2):165-173. doi: 10.1001/jamaophthalmol.2020.5664.
PubMed 33331850Shenoy BH, Mittal V, Gupta A, Sachdeva V, Kekunnaya R. Complications and visual outcomes after secondary intraocular lens implantation in children. Am J Ophthalmol. 2015 Apr;159(4):720-6. doi: 10.1016/j.ajo.2015.01.002. Epub 2015 Jan 9.
PubMed 25579641Zhao YE, Gong XH, Zhu XN, Li HM, Tu MJ, Coursey TG, Pflugfelder SC, Gu F, Chen D. Long-term outcomes of ciliary sulcus versus capsular bag fixation of intraocular lenses in children: An ultrasound biomicroscopy study. PLoS One. 2017 Mar 16;12(3):e0172979. doi: 10.1371/journal.pone.0172979. eCollection 2017.
PubMed 28301497Whitman MC, Vanderveen DK. Complications of pediatric cataract surgery. Semin Ophthalmol. 2014 Sep-Nov;29(5-6):414-20. doi: 10.3109/08820538.2014.959192.
PubMed 25325868Zou Y, Jin L, Qu B, Chen H, Zeng M, Li X, Liu X, Luo L, Liu Z, Liu Y. Safety and efficacy in pediatric secondary intraocular lens implantation, in-the-bag versus sulcus implantation: a multicenter, single-blinded randomized controlled trial. Trials. 2023 Jun 9;24(1):388. doi: 10.1186/s13063-023-07411-z.
PubMed 37296411
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence of Glaucoma-related Adverse Events in Pediatric Secondary Intraocular Lens Implantation, In-the-bag Versus Sulcus Fixation : a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05136950
- Acronym / sponsor ID
- 2021KYPJ135
- Conditions
- Lens Implantation, Intraocular
- Keywords
- Pediatric aphakia, Secondary Intraocular Lens Implantation, Glaucoma-related Adverse Events, In-the-bag IOL implantation, Sulcus IOL fixation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 228 participants (estimated)
- Lead sponsor
- Zhongshan Ophthalmic Center, Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 14 Dec 2021 (actual)
- Primary completion
- 30 Jul 2023 (estimated)
- Study completion
- 30 Jul 2033 (estimated)
- First posted
- 30 Nov 2021 (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.
To compare the incidence of glaucoma-related adverse events of in-the-bag versus ciliary-sulcus-fixed secondary intraocular lens (IOL) implantation in pediatric aphakia
Detailed description
Treatment of pediatric cataract, one of the leading causes of childhood blindness globally, remains challenging because of extremely high incidence of glaucoma-related adverse events (AEs) after IOL implantation. The investigators aim to compare the incidence of glaucoma-related AEs of in-the-bag versus ciliary-sulcus-fixed secondary intraocular lens (IOL) implantation in pediatric aphakia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Secondary in-the-bag IOL fixation group | Experimental | Procedure: Secondary in-the-bag IOL fixationIn-the-bag IOL fixation is the experimental arm |
| Secondary ciliary sulcus IOL fixation group | Active comparator | Procedure: Secondary ciliary sulcus IOL fixationCiliary sulcus IOL fixation is the control arm |
Who may qualify
- Ages
- 18 months to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Aged between 18 months and 14 years
- Had a primary diagnosis of congenital cataract.
- Underwent cataract extraction between the ages of 2 and 24 months
Key exclusion criteria (3 listed)
- Primary IOL implantation
- Pre-existing ocular disease which might affect the location and outcome of secondary IOL implantation (including and not restricted to microphthalmia, microcornea, microcornea, corneal opacity, pseudopterygium, iris anomaly, glaucoma diagnosed before cataract extraction, uveitis, persistent fetal vasculature or trauma)
- Suture fixation for secondary IOL implantation
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 |
|---|---|---|
| Secondary in-the-bag IOL fixationThe experimental group with secondary IOL fixated in the capsular bag | Procedure or surgery | Secondary in-the-bag IOL fixation group |
| Secondary ciliary sulcus IOL fixationThe control group with secondary IOL fixated in the ciliary sulcus | Procedure or surgery | Secondary ciliary sulcus IOL fixation group |
Primary outcome
Incidence of glaucoma-related adverse events
Time frame: One year after surgery
The assessment of glaucoma-related adverse events is performed at one year after surgery
6 secondary outcomes
Incidence of glaucoma-related adverse events
Time frame: Six months,three years, five years, ten years after surgery
Visual acuity
Time frame: Six months,one year, three years, five years, ten years after surgery
Ocular refractive power
Time frame: Six months,one year,three years, five years, ten years after surgery
Intraocular lens decentration
Time frame: Six months,one year, three years, five years, ten years after surgery
Intraocular lens tilt
Time frame: Six months,one year, three years, five years, ten years after surgery
Incidence of other adverse events
Time frame: Six months,one year, three years, five years, ten years after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2022.
- Results publication: PubMed 34653355Liu Z, Lin H, Jin G, Tan X, Qu B, Jin L, Chen X, Wang W, Han X, Xu J, Ying G, Han Y, He M, Congdon N, Chen W, Luo L, Liu Y. In-the-Bag Versus Ciliary Sulcus Secondary Intraocular Lens Implantation for Pediatric Aphakia: A Prospective Comparative Study. Am J Ophthalmol. 2022 Apr;236:183-192. doi: 10.1016/j.ajo.2021.10.006. Epub 2021 Oct 13.
- Results publication: PubMed 27367747Wood KS, Tadros D, Trivedi RH, Wilson ME. Secondary intraocular lens implantation following infantile cataract surgery: intraoperative indications, postoperative outcomes. Eye (Lond). 2016 Sep;30(9):1182-6. doi: 10.1038/eye.2016.131. Epub 2016 Jul 1.
- Results publication: PubMed 33331850Freedman SF, Beck AD, Nizam A, Vanderveen DK, Plager DA, Morrison DG, Drews-Botsch CD, Lambert SR; Infant Aphakia Treatment Study Group. Glaucoma-Related Adverse Events at 10 Years in the Infant Aphakia Treatment Study: A Secondary Analysis of a Randomized Clinical Trial. JAMA Ophthalmol. 2021 Feb 1;139(2):165-173. doi: 10.1001/jamaophthalmol.2020.5664.
- Results publication: PubMed 25579641Shenoy BH, Mittal V, Gupta A, Sachdeva V, Kekunnaya R. Complications and visual outcomes after secondary intraocular lens implantation in children. Am J Ophthalmol. 2015 Apr;159(4):720-6. doi: 10.1016/j.ajo.2015.01.002. Epub 2015 Jan 9.
- Results publication: PubMed 28301497Zhao YE, Gong XH, Zhu XN, Li HM, Tu MJ, Coursey TG, Pflugfelder SC, Gu F, Chen D. Long-term outcomes of ciliary sulcus versus capsular bag fixation of intraocular lenses in children: An ultrasound biomicroscopy study. PLoS One. 2017 Mar 16;12(3):e0172979. doi: 10.1371/journal.pone.0172979. eCollection 2017.
- Results publication: PubMed 25325868Whitman MC, Vanderveen DK. Complications of pediatric cataract surgery. Semin Ophthalmol. 2014 Sep-Nov;29(5-6):414-20. doi: 10.3109/08820538.2014.959192.
- Derived from this study: PubMed 37296411Zou Y, Jin L, Qu B, Chen H, Zeng M, Li X, Liu X, Luo L, Liu Z, Liu Y. Safety and efficacy in pediatric secondary intraocular lens implantation, in-the-bag versus sulcus implantation: a multicenter, single-blinded randomized controlled trial. Trials. 2023 Jun 9;24(1):388. doi: 10.1186/s13063-023-07411-z.
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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.
Yizhi Liu, PhD principal investigator
Zhongshan Ophthalmic center, Guangzhou, People's Republic of China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Secondary in-the-bag IOL fixation and Secondary ciliary sulcus IOL fixation in people with Lens Implantation, Intraocular, run by Zhongshan Ophthalmic Center, Sun Yat-sen University at 1 site 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 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: looking for participants now, as of the sponsor's last update on 11 Jan 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 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zhenzhen Liu, PhD (+86 13570382241, liu_zhenzhen@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of glaucoma-related adverse events (time frame: One year after surgery). 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 NCT05136950, which also lists 7 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 11 Jan 2022.