Cataract, JuvenileNCT05461040
Optic Capture Without Anterior Vitrectomy in Pediatric Cataract Surgery
A study testing optic capture and In-the-bag implantation of Intraocular lens in people with Cataract, Juvenile, run by Ege University at 1 site in Turkey (Türkiye).
Trial summary
Purpose: To compare two pediatric cataract surgery procedures: intraocular lens (IOL) optic capture without anterior vitrectomy (AV) and in-the-bag IOL implantation with AV. Setting: Ege University Medical School Hospital, Izmir, Turkey. Design: Prospective randomized control clinical trial. Read more about this study
- Who is it for?
- Ages 1 year to 10 years
- Conditions the study is for
- Cataract, Juvenile
- What is being tested?
- optic capture and In-the-bag implantation of Intraocular lens
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Apr 2018to 30 Apr 2021
- 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 1 year to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children with congenital or developmental cataracts who had cataract surgery and primary IOL implantation at a tertiary care referral institute were included.
Who cannot join
- Traumatic or uveitic cataract, corneal opacity, iris coloboma, microphthalmia, microcornea, persistent fetal vascularization, congenital glaucoma, and retinopathy of prematurity were all considered exclusion criteria.
Trial locations and contacts
1 site in 1 country.
About this study
Purpose: To compare two pediatric cataract surgery procedures: intraocular lens (IOL) optic capture without anterior vitrectomy (AV) and in-the-bag IOL implantation with AV.
Setting: Ege University Medical School Hospital, Izmir, Turkey. Design: Prospective randomized control clinical trial. Methods: Patients were randomly assigned to two groups: optic capture without AV (Group 1) or in-the-bag implantation with AV (Group 2). The following variables were compared: visual acuity, intraocular pressure, refractive errors, IOL tilt and decentration, lenticular astigmatism, anterior-posterior synechia, inflammatory cell deposits on IOL and post-operative complications.
- Conditions
- Cataract, Juvenile
- Being tested
- optic capture, In-the-bag implantation of Intraocular lens
- Keywords
- cataract surgery; intraocular lens; optic capture; pediatric cataract; posterior capsulotomy
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
optic captureProcedure or surgery
optic capture of Intraocular lens without anterior vitrectomy
In-the-bag implantation of Intraocular lensProcedure or surgery
in-the-bag implantation of Intraocular lens with anterior vitrectomy
| Study group | Role | What they receive |
|---|---|---|
| Optic capture of Intraocular lens without anterior vitrectomy (Group 1) | Experimental | Not described Receives: Procedure: optic capture |
| in-the-bag implantation of Intraocular lens with anterior vitrectomy (Group 2). | Experimental | Not described Receives: Procedure: In-the-bag implantation of Intraocular lens |
What is being measured
The primary outcome is the main question the study is designed to answer.
The prevalence of visual axis opacification
Eyes were evaluated for presence of visual axis opacification at the slit lamp examinations.
Measured: through study completion, an average of 2 years
The prevalence of inflammatory deposits on Intraocular lens surface
Eyes were evaluated presence of inflammatory deposits between the margins of capsulorhexis at the slit lamp examinations.
Measured: through study completion, an average of 2 years
The prevalence of anterior-posterior synechia
Eyes were evaluated for presence of anterior-posterior synechia at the slit lamp examinations.
Measured: through study completion, an average of 2 years
Measurements of Intraocular lens tilt and decentration.
Measurement of Intraocular lens (IOL) position at vertical and horizontal meridians at the Scheimpflug images captured with corneal topography. Scheimpflug images were obtained (Pentacam HR, Oculus Optikgerate Gmbh, Wetzlar, Germany) at one postoperative year. The horizontal and vertical meridians' photographs were analyzed.These images were processed in AutoCAD LT 2020 2D CAD software for IOL position assessment.(1) IOL Center: Two arches were drawn that fit perfectly on the anterior and posterior surfaces of the IOL. The points where these two arcs met were marked. Between these intersection points, a line was drawn. The midpoint of this line was accepted as the IOL center. (2) IOL Decentration: It was determined by measuring the distance (mm) from the IOL center point to the pupillary axis. (3) IOL Tilt: Angle (degree) between the IOL axis and the line passing through the iridocorneal angle.
Measured: at the postoperative one-year
Prediction error
Refraction prediction error (PE) was found by subtracting the early post-operative refraction from the pre-operative target refraction.
Measured: at the post-operative one-month
Secondary outcomes (3)
Intraocular pressure
Intraocular pressure was measured by Tonopen (Reichart Technologies, Depew, NY), Perkins handheld Mk2 tonometry (Haag-Streit, Koeniz, Switzerland) or Goldmann applanation tonometry (Haag Streit, Koeniz, Switzerland), considering the patient's age and compliance.
Measured: at the postoperative one year
Lenticular astigmatism
Calculated by subtracting corneal astigmatism from manifest astigmatism.
Measured: One-year postoperatively
Posterior segment complications
In the fundoscopic examination, the patients were evaluated for possible posterior segment complications such as retinal detachment, cystoid macular edema, and intraocular hemorrhage.
Measured: through study completion, an average of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2022
- Study start30 Apr 2018
- Primary completion30 Apr 2021
- Study completion30 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cataract, JuvenileStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ege University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ali Devebacak, Ege University
- Investigators
- Ali Devebacak, M.D., Principal investigator, Ege University, Department of Ophthalmology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05461040
- Sponsor's protocol ID
- OC3506
- Status last verified
- Jul 2022
- First submitted
- 11 Jul 2022
- Last updated
- 15 Jul 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optic Capture Without Anterior Vitrectomy in Pediatric Cataract Surgery
- ClinicalTrials.gov ID
- NCT05461040
- Acronym / sponsor ID
- OC3506
- Conditions
- Cataract, Juvenile
- Keywords
- cataract surgery; intraocular lens; optic capture; pediatric cataract; posterior capsulotomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Ege UniversityUniversity, hospital or other
- Study start
- 30 Apr 2018 (actual)
- Primary completion
- 30 Apr 2021 (actual)
- Study completion
- 30 Apr 2021 (actual)
- First posted
- 15 Jul 2022 (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.
Purpose: To compare two pediatric cataract surgery procedures: intraocular lens (IOL) optic capture without anterior vitrectomy (AV) and in-the-bag IOL implantation with AV.
Setting: Ege University Medical School Hospital, Izmir, Turkey. Design: Prospective randomized control clinical trial. Methods: Patients were randomly assigned to two groups: optic capture without AV (Group 1) or in-the-bag implantation with AV (Group 2). The following variables were compared: visual acuity, intraocular pressure, refractive errors, IOL tilt and decentration, lenticular astigmatism, anterior-posterior synechia, inflammatory cell deposits on IOL and post-operative complications.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Optic capture of Intraocular lens without anterior vitrectomy (Group 1) | Experimental | Procedure: optic capture |
| in-the-bag implantation of Intraocular lens with anterior vitrectomy (Group 2). | Experimental | Procedure: In-the-bag implantation of Intraocular lens |
Who may qualify
- Ages
- 1 year to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Children with congenital or developmental cataracts who had cataract surgery and primary IOL implantation at a tertiary care referral institute were included.
Key exclusion criteria (1 listed)
- Traumatic or uveitic cataract, corneal opacity, iris coloboma, microphthalmia, microcornea, persistent fetal vascularization, congenital glaucoma, and retinopathy of prematurity were all considered exclusion criteria.
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 |
|---|---|---|
| optic captureoptic capture of Intraocular lens without anterior vitrectomy | Procedure or surgery | Optic capture of Intraocular lens without anterior vitrectomy (Group 1) |
| In-the-bag implantation of Intraocular lensin-the-bag implantation of Intraocular lens with anterior vitrectomy | Procedure or surgery | in-the-bag implantation of Intraocular lens with anterior vitrectomy (Group 2). |
Primary outcome
The prevalence of visual axis opacification
Time frame: through study completion, an average of 2 years
Eyes were evaluated for presence of visual axis opacification at the slit lamp examinations.
The prevalence of inflammatory deposits on Intraocular lens surface
Time frame: through study completion, an average of 2 years
Eyes were evaluated presence of inflammatory deposits between the margins of capsulorhexis at the slit lamp examinations.
The prevalence of anterior-posterior synechia
Time frame: through study completion, an average of 2 years
Eyes were evaluated for presence of anterior-posterior synechia at the slit lamp examinations.
Measurements of Intraocular lens tilt and decentration.
Time frame: at the postoperative one-year
Measurement of Intraocular lens (IOL) position at vertical and horizontal meridians at the Scheimpflug images captured with corneal topography. Scheimpflug images were obtained (Pentacam HR, Oculus Optikgerate Gmbh, Wetzlar, Germany) at one postoperative year. The horizontal and vertical meridians' photographs were analyzed.These images were processed in AutoCAD LT 2020 2D CAD software for IOL position assessment.(1) IOL Center: Two arches were drawn that fit perfectly on the anterior and posterior surfaces of the IOL. The points where these two arcs met were marked. Between these intersection points, a line was drawn. The midpoint of this line was accepted as the IOL center. (2) IOL Decentration: It was determined by measuring the distance (mm) from the IOL center point to the pupillary axis. (3) IOL Tilt: Angle (degree) between the IOL axis and the line passing through the iridocorneal angle.
Prediction error
Time frame: at the post-operative one-month
Refraction prediction error (PE) was found by subtracting the early post-operative refraction from the pre-operative target refraction.
3 secondary outcomes
Intraocular pressure
Time frame: at the postoperative one year
Lenticular astigmatism
Time frame: One-year postoperatively
Posterior segment complications
Time frame: through study completion, an average of 2 years
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 15 Jul 2022.
- Individual participant dataSharing planned: Undecided
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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.
Ali Devebacak, M.D. principal investigator
Ege University, Department of Ophthalmology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing optic capture and In-the-bag implantation of Intraocular lens in people with Cataract, Juvenile, run by Ege University at 1 site in Turkey (Türkiye).
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 1 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 15 Jul 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 Turkey (Türkiye). 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 prevalence of visual axis opacification (time frame: through study completion, an average of 2 years). The study lists 5 primary outcomes in all. 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 15 Jul 2022.