Cataract, Posterior Capsule Opacification
Conditions
Brief summary
In this study, the investigators introduce a new capsule-reserved cataract surgical procedure in which anterior lens capsule is reserved and attached onto posterior lens capsule in the purpose of preventing posterior capsule opacification (PCO). A prospective randomized controlled study is reported to compare the new capsule-reserved surgical procedure with conventional one on the effectiveness to prevent posterior capsule opacification in age-related cataract patients.
Detailed description
A prospective, randomized controlled study of 240 eligible patients will been enrolled. Two eyes of each patient were assigned randomly to two groups respectively: Group I; anterior lens capsule is conventionally not reserved after continuous curvilinear capsulorhexis, while in Group II, anterior lens capsule is innovatively reserved and attached onto posterior lens capsule. This novel adjusted surgical procedure, featured by using the reserved anterior lens capsule to protect the peri-capsule microenvironment and prevent PCO, is conceptual different from the traditional cataract surgical procedure. Clinical examinations including posterior capsule opacification grading score, central posterior capsule thickness, central posterior capsule density, best corrected visual acuity, contrast sensitivity were carried out preoperatively and at each postoperative visit.
Interventions
PROCEDUREAnterior lens capsule was reserved
The anterior lens capsule was reserved after continuous curvilinear capsulorhexis. The reserved anterior capsule was pressed flattened by the optical surface of the IOL and attached onto the posterior lens capsule.
Sponsors
Sun Yat-sen University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
50 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
1. Aged 50 years or above 2. Both eyes were diagnosed with age-related cataract 3. Both eyes were planed to undergo the Phacoemulsification and IOL implantation surgery with 1 month 4. Biocular BCVA improvement post surgery was feasible judged by the ophthalmologists.
Exclusion criteria
1. Other ocular diseases 2. ACD\<3CT 3. Combined cataract surgery (trabeculoplasty, keratoplasty) 4. Lens pseudoexfoliation syndrome combined with glaucoma or zonular abnormalities 5. Previous intraocular surgery or trauma (laser not included) 6. Uveitis 7. Recent ocular infection 8. Proliferative diabetic retinopathy 9. Diabetes mellitus 10. Congenital ocular abnormalities (aniridia, congenital cataract) 11. Atrophy of iris 12. Participants with previous clinical trials 30 days before surgery 13. Using prostanoid eye drops 14. Uncontrolled systematic diseases
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline in posterior capsule opacification grading score | post-operative day 1, post-operative week 1, post-operative month 1, post-operative month 3, | Posterior capsule opacification（PCO）was recorded by standardized slit lamp retroillumination images and analyzed using the EPCO2000 program. The severity of PCO was clinically graded from 0 (none) to 4 (severe) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline in central posterior capsule thickness | post-operative day 1, post-operative week 1, post-operative month 1, post-operative month 3, post-operative month 6, post-operative year 1 | Central posterior capsule thickness was recorded and calculated by Pentacam HR system |
| Change from Baseline in central posterior capsule density | post-operative day 1, post-operative week 1, post-operative month 1, post-operative month 3, post-operative month 6, post-operative year 1 | Central posterior capsule density was recorded and calculated by Pentacam HR system. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline in best corrected visual acuity | post-operative day 1, post-operative week 1, post-operative month 1, post-operative month 3, post-operative month 6, post-operative year 1 | Best-corrected visual acuity (BCVA) was measured, using an ETDRS chart and auto-refraction as refined by an ophthalmologist. |
| Change from Baseline in contrast sensitivity | post-operative day 1, post-operative week 1, post-operative month 1, post-operative month 3, post-operative month 6, post-operative year 1 | Contrast sensitivity under mesopic and photopic conditions was measured using C-quant |
Countries
China
Contacts
Primary ContactHaotian Lin, M.D., PhD
Backup ContactXiaohang Wu, M.D.
Outcome results
None listed