Two Different Cataract Surgical Procedures to Prevent Posterior Capsule Opacification

Sponsor
Sun Yat-sen University (Other)
Overall Status
Unknown status
CT.gov ID
NCT02445274
Collaborator
(none)
240
1
2
15
15.9

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Anterior lens capsule was reserved
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
240 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
Effectiveness of Two Different Surgical Procedures to Prevent Posterior Capsule Opacification in Age-related Cataract Patients
Study Start Date :
May 1, 2015
Anticipated Primary Completion Date :
Aug 1, 2016
Anticipated Study Completion Date :
Aug 1, 2016

Arms and Interventions

Arm Intervention/Treatment
Experimental: Capsule-reserved surgical procedure

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.

Procedure: Anterior 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.

No Intervention: Conventional surgical procedure

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

Outcome Measures

Primary Outcome Measures

  1. 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 Outcome Measures

  1. 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

  2. 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 Outcome Measures

  1. 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.

  2. 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

Eligibility Criteria

Criteria

Ages Eligible for Study:
50 Years to 90 Years
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Zhognshan Ophthalmic Center, Sun Yat-sen University Guangzhou Guangdong China 510060

Sponsors and Collaborators

  • Sun Yat-sen University

Investigators

  • Principal Investigator: Yizhi Liu, M.D., PhD, Zhongshan Ophthalmic Center, Sun Yat-sen University

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

Responsible Party:
Haotian Lin, Associate Professor, Sun Yat-sen University
ClinicalTrials.gov Identifier:
NCT02445274
Other Study ID Numbers:
  • 2015MEKY046
First Posted:
May 15, 2015
Last Update Posted:
May 3, 2016
Last Verified:
Apr 1, 2016
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 3, 2016