CataractNCT03701139
Posterior Capsulotomy in Cataract Complicated With Primary Posterior Capsule Opacification.
A study testing posterior capsulotomy and laser capsulotomy in people with Cataract and Posterior Capsule Opacification, run by Zhongshan Ophthalmic Center, Sun Yat-sen University at 1 site in China.
Trial summary
This is a two-arm, parallel group, open-label, randomized controlled trial to compare the visual acuity, visual quality, operative complications and the satisfaction of patients between primary posterior capsulorhexis group and laser capsulotomy group of cataract patients combined with primary posterior capsular… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cataract, Posterior Capsule Opacification
- What is being tested?
- posterior capsulotomy and laser capsulotomy
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 10 Oct 2018to Feb 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Cataract patients with primary posterior capsular opacification, which involves the central posterior capsular and interferes with visual axis;
- Aged 18 years or over;
- With best corrected visual acuity (BCVA) less than 0.3.
Who cannot join
- History of other eye disease that contributes to visual impairment, including keratopathy, uveitis, glaucoma, retinopathy, ocular trauma, or intraocular surgery.
- Cases with operative complications, including anterior or posterior capsular rupture, lens suspensory ligament rupture, the falling of lens nucleus into vitreous cavity.
- Unwillingness to participate in the study.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Zhongshan Ophthalmic Center, Sun Yat-sen University
Guangzhou, Guangdong, 510060
Xuhua Tan, PhD, +86-13926019722, doctxh@163.com
Xiaozhang Qiu, Bachelor, +86-13751871820, 625215149@qq.com
About this study
Official title: Phacoemulsification Combined With Posterior Capsulotomy in Cataract Complicated With Primary Posterior Capsule Opacification: a Randomized Controlled Trial
This is a two-arm, parallel group, open-label, randomized controlled trial to compare the visual acuity, visual quality, operative complications and the satisfaction of patients between primary posterior capsulorhexis group and laser capsulotomy group of cataract patients combined with primary posterior capsular opacification (PPCO).
Read the detailed description
Primary posterior capsular opacification (PPCO) refers to the posterior capsule opacification which cannot be removed by polishing or vacuuming during cataract surgery. The surgeon may have to decide on primary posterior capsulorhexis or early neodymium-doped yttrium aluminum garnet (Nd:YAG) laser capsulotomy in these cases. The aim of this study is to compare the visual acuity, visual quality, operative complications and the satisfaction of patients between primary posterior capsulorhexis group and laser capsulotomy group of cataract patients combined with primary posterior capsular opacification (PPCO).
- Conditions
- Cataract, Posterior Capsule Opacification
- Being tested
- posterior capsulotomy, laser capsulotomy
- Keywords
- phacoemulsification, cataract, primary posterior capsule opacification, posterior capsulotomy, randomized controlled trial, Nd:YAG laser capsulotomy
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
posterior capsulotomyProcedure or surgery
After phacoemulsification with intraocular lens implantation, primary posterior capsulotomy will be performed to remove the primary posterior capsule opacification after posterior capsule polishing. A limited anterior vitrectomy will be performed if the anterior hyaloid surface is broken.
laser capsulotomyProcedure or surgery
A routine phacoemulsification with intraocular lens implantation is performed. Then the Nd:YAG laser capsulotomy will be performed 1 month postoperative to remove the primary posterior capsule opacification.
| Study group | Role | What they receive |
|---|---|---|
| posterior capsulotomy | Experimental | Primary posterior capsulotomy will be performed to remove the primary posterior capsule opacification after posterior capsule polishing during phacoemulsification. Receives: Procedure: posterior capsulotomy |
| Nd:YAG laser capsulotomy | Active comparator | Nd:YAG laser capsulotomy will be performed 1 month postoperative to remove the primary posterior capsule opacification. Receives: Procedure: laser capsulotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
LogMAR visual acuity 1 month postoperatively
Best corrected visual acuity (LogMAR) will be measured 1 month postoperatively.
Measured: 1 month
Secondary outcomes (11)
Dysfunctional lens index (DLI)
The dysfunctional lens index (DLI) is an objective lens performance metric derived from internal higher order aberrations (HOAs), pupil size, and contrast sensitivity data. DLI is a score ranged from 0 to 10. DLI will be measured by iTrace aberrometer.
Measured: 3 months
Internal higher order aberration (HOAs)
TInternal higher order aberration (HOAs) in micrometer can quantify the intraocular optical quality and will be measured by iTrace aberrometer.
Measured: 3 months
Object scatter index (OSI)
Object scatter index (OSI) is a ratio of 12 and 20 points from the perspective of the annular region of the light and the central 1 point perspective peak. OSI can objectively evaluate the amount of intraocular scattering and is an important index of optical quality. OSI is a score ranged from 0 to 10 and will be measured by Optical Quality Analysis System (OQAS).
Measured: 3 months
Modulation transfer function cut off (MTF cut off)
Modulation transfer function cut off (MTF cut off) relates directly to retinal image quality and is a useful indicator of visual performance in cataract eyes. MTF cut off will be measured by OQAS.
Measured: 3 months
Strehl ratio (SR)
Strehl ratio (SR) is computed as the ratio between the areas under the MTF curve of the measured eye and that of the aberration-free eye, and therefore it provides more global information on the optical quality. SR is a score ranged from 0 to 1 and will be measured by OQAS.
Measured: 3 months
Predicted visual acuity (PVA) with contrasts of 100%, 20% and 10%
Predicted visual acuity (PVA) with contrasts of 100%, 20% and 10% correspond to three specific frequencies of the MTF that describe the eye's optical quality for the contrast values mentioned. In general, PVAs higher than 1 are associated to very high retinal image quality. PVA will be measured by OQAS.
Measured: 3 months
Rate of ocular hypertension
Diagnosis of ocular hypertension is based on IOP greater than 21 mm Hg and the rate of ocular hypertension is calculated.
Measured: 3 months
Rate of ocular macular edema
The central macular thickness in micrometer is measured by optical coherence tomography (OCT) and the rate of ocular macular edema is calculated.
Measured: 3 months
Rate of retinal detachment
Retinal detachment following surgical or laser posterior capsulotomy is documented and the rate of Retinal detachment is calculated.
Measured: 3 months
Rate of intraocular lens damage
The rate of intraocular lens damage by Nd:YAG laser is documented.
Measured: 3 months
Visual-functioning index 7 score
Subjective satisfaction of patients is investigated by visual-functioning index 7 (VF-7) questionnaire. The VF-7 questionnaire comprises 7 questions for performing daily-life activities (1= a great deal of difficulty; 2= a moderate amount difficulty; 3= a little difficulty; 4= no difficulty). The VF-7 score is the average score of these 7 activities multiplied by 25, to give a final score between 0 and 100.
- nighttime driving;
- reading small print;
- watching television;
- seeing steps, stairs, or curbs;
- reading traffic, street, or store signs;
- cooking;
- doing fine handwork
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2018
- Study start10 Oct 2018
- Primary completionFeb 2019 (estimated)
- Study completionFeb 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CataractStudies 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
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- 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 Ophthamic Center,Sun Yet-san University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03701139
- Sponsor's protocol ID
- 2018KYPJ103
- Status last verified
- Oct 2018
- First submitted
- 2 Oct 2018
- Last updated
- 17 Oct 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phacoemulsification Combined With Posterior Capsulotomy in Cataract Complicated With Primary Posterior Capsule Opacification: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03701139
- Acronym / sponsor ID
- 2018KYPJ103
- Conditions
- Cataract, Posterior Capsule Opacification
- Keywords
- phacoemulsification, cataract, primary posterior capsule opacification, posterior capsulotomy, randomized controlled trial, Nd:YAG laser capsulotomy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Zhongshan Ophthalmic Center, Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 10 Oct 2018 (actual)
- Primary completion
- Feb 2019 (estimated)
- Study completion
- Feb 2019 (estimated)
- First posted
- 9 Oct 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 two-arm, parallel group, open-label, randomized controlled trial to compare the visual acuity, visual quality, operative complications and the satisfaction of patients between primary posterior capsulorhexis group and laser capsulotomy group of cataract patients combined with primary posterior capsular opacification (PPCO).
Detailed description
Primary posterior capsular opacification (PPCO) refers to the posterior capsule opacification which cannot be removed by polishing or vacuuming during cataract surgery. The surgeon may have to decide on primary posterior capsulorhexis or early neodymium-doped yttrium aluminum garnet (Nd:YAG) laser capsulotomy in these cases. The aim of this study is to compare the visual acuity, visual quality, operative complications and the satisfaction of patients between primary posterior capsulorhexis group and laser capsulotomy group of cataract patients combined with primary posterior capsular opacification (PPCO).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| posterior capsulotomy | Experimental | Procedure: posterior capsulotomyPrimary posterior capsulotomy will be performed to remove the primary posterior capsule opacification after posterior capsule polishing during phacoemulsification. |
| Nd:YAG laser capsulotomy | Active comparator | Procedure: laser capsulotomyNd:YAG laser capsulotomy will be performed 1 month postoperative to remove the primary posterior capsule opacification. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Cataract patients with primary posterior capsular opacification, which involves the central posterior capsular and interferes with visual axis;
- Aged 18 years or over;
- With best corrected visual acuity (BCVA) less than 0.3.
Key exclusion criteria (3 listed)
- History of other eye disease that contributes to visual impairment, including keratopathy, uveitis, glaucoma, retinopathy, ocular trauma, or intraocular surgery.
- Cases with operative complications, including anterior or posterior capsular rupture, lens suspensory ligament rupture, the falling of lens nucleus into vitreous cavity.
- Unwillingness to participate in the study.
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 |
|---|---|---|
| posterior capsulotomyAfter phacoemulsification with intraocular lens implantation, primary posterior capsulotomy will be performed to remove the primary posterior capsule opacification after posterior capsule polishing. A limited anterior vitrectomy will be performed if the anterior hyaloid surface is broken. | Procedure or surgery | posterior capsulotomy |
| laser capsulotomyA routine phacoemulsification with intraocular lens implantation is performed. Then the Nd:YAG laser capsulotomy will be performed 1 month postoperative to remove the primary posterior capsule opacification. | Procedure or surgery | Nd:YAG laser capsulotomy |
Primary outcome
LogMAR visual acuity 1 month postoperatively
Time frame: 1 month
Best corrected visual acuity (LogMAR) will be measured 1 month postoperatively.
11 secondary outcomes
Dysfunctional lens index (DLI)
Time frame: 3 months
Internal higher order aberration (HOAs)
Time frame: 3 months
Object scatter index (OSI)
Time frame: 3 months
Modulation transfer function cut off (MTF cut off)
Time frame: 3 months
Strehl ratio (SR)
Time frame: 3 months
Predicted visual acuity (PVA) with contrasts of 100%, 20% and 10%
Time frame: 3 months
Rate of ocular hypertension
Time frame: 3 months
Rate of ocular macular edema
Time frame: 3 months
Rate of retinal detachment
Time frame: 3 months
Rate of intraocular lens damage
Time frame: 3 months
Visual-functioning index 7 score
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2018.
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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 Ophthamic Center,Sun Yet-san 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 posterior capsulotomy and laser capsulotomy in people with Cataract and Posterior Capsule Opacification, 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: status not confirmed, as of the sponsor's last update on 17 Oct 2018. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xuhua Tan, PhD (+8613926019722, doctxh@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
LogMAR visual acuity 1 month postoperatively (time frame: 1 month). 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 17 Oct 2018.