Two Different Cataract Surgical Procedures to Prevent Posterior Capsule Opacification

Sun Yat-sen University

Status: Unknown

Conditions: Cataract; Posterior Capsule Opacification

Treatments: Procedure: Anterior lens capsule was reserved

Study type: Interventional

Funder types: Other

Identifiers

NCT02445274

2015MEKY046

Details and patient eligibility

About

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.

Full 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.

Enrollment: 240 estimated patients

Sex: All

Ages: 50 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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240 participants in 2 patient groups

Capsule-reserved surgical procedure

Experimental group

Description:

In this group, 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. Phacoemulsification was performed with the same device and handpieces, using the same phaco chop technique as in the conventional procedure group.

Treatment:

Procedure: Anterior lens capsule was reserved

Conventional surgical procedure

No Intervention group

Description:

In this group, the anterior lens capsule was not reserved or attached onto the posterior lens capsule.