Back to resultsPosterior Capsulotomy in Cataract Complicated With Primary Posterior Capsule Opacification.
Primary Purpose
Cataract, Posterior Capsule Opacification
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
posterior capsulotomy
laser capsulotomy
Sponsored by
About this trial
This is an interventional treatment trial for Cataract focused on measuring phacoemulsification, cataract, primary posterior capsule opacification, posterior capsulotomy, randomized controlled trial, Nd:YAG laser capsulotomy
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Sites / Locations
- Zhongshan Ophthalmic Center, Sun Yat-sen UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
posterior capsulotomy
Nd:YAG laser capsulotomy
Arm Description
Primary posterior capsulotomy will be performed to remove the primary posterior capsule opacification after posterior capsule polishing during phacoemulsification.
Nd:YAG laser capsulotomy will be performed 1 month postoperative to remove the primary posterior capsule opacification.
Outcomes
Primary Outcome Measures
LogMAR visual acuity 1 month postoperatively
Best corrected visual acuity (LogMAR) will be measured 1 month postoperatively.
Secondary Outcome Measures
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.
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.
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).
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.
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.
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.
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.
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.
Rate of retinal detachment
Retinal detachment following surgical or laser posterior capsulotomy is documented and the rate of Retinal detachment is calculated.
Rate of intraocular lens damage
The rate of intraocular lens damage by Nd:YAG laser is documented.
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
Full Information
NCT ID
NCT03701139
First Posted
October 2, 2018
Last Updated
October 15, 2018
Sponsor
Zhongshan Ophthalmic Center, Sun Yat-sen University
1. Study Identification
Unique Protocol Identification Number
NCT03701139
Brief Title
Posterior Capsulotomy in Cataract Complicated With Primary Posterior Capsule Opacification.
Official Title
Phacoemulsification Combined With Posterior Capsulotomy in Cataract Complicated With Primary Posterior Capsule Opacification: a Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
October 2018
Overall Recruitment Status
Unknown status
Study Start Date
October 10, 2018 (Actual)
Primary Completion Date
February 2019 (Anticipated)
Study Completion Date
February 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Zhongshan Ophthalmic Center, Sun Yat-sen University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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 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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataract, Posterior Capsule Opacification
Keywords
phacoemulsification, cataract, primary posterior capsule opacification, posterior capsulotomy, randomized controlled trial, Nd:YAG laser capsulotomy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
posterior capsulotomy
Arm Type
Experimental
Arm Description
Primary posterior capsulotomy will be performed to remove the primary posterior capsule opacification after posterior capsule polishing during phacoemulsification.
Arm Title
Nd:YAG laser capsulotomy
Arm Type
Active Comparator
Arm Description
Nd:YAG laser capsulotomy will be performed 1 month postoperative to remove the primary posterior capsule opacification.
Intervention Type
Procedure
Intervention Name(s)
posterior capsulotomy
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
laser capsulotomy
Intervention Description
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.
Primary Outcome Measure Information:
Title
LogMAR visual acuity 1 month postoperatively
Description
Best corrected visual acuity (LogMAR) will be measured 1 month postoperatively.
Time Frame
1 month
Secondary Outcome Measure Information:
Title
Dysfunctional lens index (DLI)
Description
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.
Time Frame
3 months
Title
Internal higher order aberration (HOAs)
Description
TInternal higher order aberration (HOAs) in micrometer can quantify the intraocular optical quality and will be measured by iTrace aberrometer.
Time Frame
3 months
Title
Object scatter index (OSI)
Description
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).
Time Frame
3 months
Title
Modulation transfer function cut off (MTF cut off)
Description
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.
Time Frame
3 months
Title
Strehl ratio (SR)
Description
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.
Time Frame
3 months
Title
Predicted visual acuity (PVA) with contrasts of 100%, 20% and 10%
Description
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.
Time Frame
3 months
Title
Rate of ocular hypertension
Description
Diagnosis of ocular hypertension is based on IOP greater than 21 mm Hg and the rate of ocular hypertension is calculated.
Time Frame
3 months
Title
Rate of ocular macular edema
Description
The central macular thickness in micrometer is measured by optical coherence tomography (OCT) and the rate of ocular macular edema is calculated.
Time Frame
3 months
Title
Rate of retinal detachment
Description
Retinal detachment following surgical or laser posterior capsulotomy is documented and the rate of Retinal detachment is calculated.
Time Frame
3 months
Title
Rate of intraocular lens damage
Description
The rate of intraocular lens damage by Nd:YAG laser is documented.
Time Frame
3 months
Title
Visual-functioning index 7 score
Description
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
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xuhua Tan, PhD
Phone
+8613926019722
Email
doctxh@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Xiaozhang Qiu, Bachelor
Phone
+8613751871820
Email
625215149@qq.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yizhi Liu, PhD
Organizational Affiliation
Zhongshan Ophthamic Center,Sun Yet-san University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Zhongshan Ophthalmic Center, Sun Yat-sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510060
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xuhua Tan, PhD
Phone
+86-13926019722
Email
doctxh@163.com
First Name & Middle Initial & Last Name & Degree
Xiaozhang Qiu, Bachelor
Phone
+86-13751871820
Email
625215149@qq.com
12. IPD Sharing Statement
Learn more about this trial
Posterior Capsulotomy in Cataract Complicated With Primary Posterior Capsule Opacification.
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