NCT03701139

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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 2, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 9, 2018

Completed
1 day until next milestone

Study Start

First participant enrolled

October 10, 2018

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2019

Completed
Last Updated

October 17, 2018

Status Verified

October 1, 2018

Enrollment Period

4 months

First QC Date

October 2, 2018

Last Update Submit

October 15, 2018

Conditions

CataractPosterior Capsule Opacification

Keywords

phacoemulsificationcataractprimary posterior capsule opacificationposterior capsulotomyrandomized controlled trialNd:YAG laser capsulotomy

Outcome Measures

Primary Outcomes (1)

  • LogMAR visual acuity 1 month postoperatively

    Best corrected visual acuity (LogMAR) will be measured 1 month postoperatively.

    1 month

Secondary Outcomes (11)

  • Dysfunctional lens index (DLI)

    3 months

  • Internal higher order aberration (HOAs)

    3 months

  • Object scatter index (OSI)

    3 months

  • Modulation transfer function cut off (MTF cut off)

    3 months

  • Strehl ratio (SR)

    3 months

  • +6 more secondary outcomes

Study Arms (2)

posterior capsulotomy

EXPERIMENTAL

Primary posterior capsulotomy will be performed to remove the primary posterior capsule opacification after posterior capsule polishing during phacoemulsification.

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.

Procedure: laser capsulotomy

Interventions

posterior capsulotomyPROCEDURE

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.

posterior capsulotomy
laser capsulotomyPROCEDURE

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.

Nd:YAG laser capsulotomy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhongshan Ophthalmic Center, Sun Yat-sen University

Guangzhou, Guangdong, 510060, China

RECRUITING

MeSH Terms

Conditions

Cataract

Interventions

Posterior Capsulotomy

Condition Hierarchy (Ancestors)

Lens DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

Refractive Surgical ProceduresOphthalmologic Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Yizhi Liu, PhD

    Zhongshan Ophthamic Center,Sun Yet-san University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Xuhua Tan, PhD

CONTACT

+8613926019722doctxh@163.com

Xiaozhang Qiu, Bachelor

CONTACT

+8613751871820625215149@qq.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor,director of Zhongshan Ophthalmic Center

Study Record Dates

First Submitted

October 2, 2018

First Posted

October 9, 2018

Study Start

October 10, 2018

Primary Completion

February 1, 2019

Study Completion

February 1, 2019

Last Updated

October 17, 2018

Record last verified: 2018-10

Locations

CN(1)