Posterior Capsulotomy in Cataract Complicated With Primary Posterior Capsule Opacification.

October 15, 2018 updated by: Yizhi Liu, Zhongshan Ophthalmic Center, Sun Yat-sen University

Phacoemulsification Combined With Posterior Capsulotomy in Cataract Complicated With Primary Posterior Capsule Opacification: a Randomized Controlled Trial

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).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510060
        • Recruiting
        • Zhongshan Ophthalmic Center, Sun Yat-sen University
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Cataract patients with primary posterior capsular opacification, which involves the central posterior capsular and interferes with visual axis;
  2. Aged 18 years or over;
  3. With best corrected visual acuity (BCVA) less than 0.3.

Exclusion Criteria:

  1. History of other eye disease that contributes to visual impairment, including keratopathy, uveitis, glaucoma, retinopathy, ocular trauma, or intraocular surgery.
  2. Cases with operative complications, including anterior or posterior capsular rupture, lens suspensory ligament rupture, the falling of lens nucleus into vitreous cavity.
  3. Unwillingness to participate in the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: posterior capsulotomy
Primary posterior capsulotomy will be performed to remove the primary posterior capsule opacification after posterior capsule polishing during phacoemulsification.
Procedure: posterior capsulotomy
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.
Active Comparator: Nd:YAG laser capsulotomy
Nd:YAG laser capsulotomy will be performed 1 month postoperative to remove the primary posterior capsule opacification.
Procedure: laser capsulotomy
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
LogMAR visual acuity 1 month postoperatively
Time Frame: 1 month
Best corrected visual acuity (LogMAR) will be measured 1 month postoperatively.
1 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dysfunctional lens index (DLI)
Time Frame: 3 months
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.
3 months
Internal higher order aberration (HOAs)
Time Frame: 3 months
TInternal higher order aberration (HOAs) in micrometer can quantify the intraocular optical quality and will be measured by iTrace aberrometer.
3 months
Object scatter index (OSI)
Time Frame: 3 months
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).
3 months
Modulation transfer function cut off (MTF cut off)
Time Frame: 3 months
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.
3 months
Strehl ratio (SR)
Time Frame: 3 months
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.
3 months
Predicted visual acuity (PVA) with contrasts of 100%, 20% and 10%
Time Frame: 3 months
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.
3 months
Rate of ocular hypertension
Time Frame: 3 months
Diagnosis of ocular hypertension is based on IOP greater than 21 mm Hg and the rate of ocular hypertension is calculated.
3 months
Rate of ocular macular edema
Time Frame: 3 months
The central macular thickness in micrometer is measured by optical coherence tomography (OCT) and the rate of ocular macular edema is calculated.
3 months
Rate of retinal detachment
Time Frame: 3 months
Retinal detachment following surgical or laser posterior capsulotomy is documented and the rate of Retinal detachment is calculated.
3 months
Rate of intraocular lens damage
Time Frame: 3 months
The rate of intraocular lens damage by Nd:YAG laser is documented.
3 months
Visual-functioning index 7 score
Time Frame: 3 months

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.

  1. nighttime driving;
  2. reading small print;
  3. watching television;
  4. seeing steps, stairs, or curbs;
  5. reading traffic, street, or store signs;
  6. cooking;
  7. doing fine handwork
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zhongshan Ophthalmic Center, Sun Yat-sen University

Investigators

  • Principal Investigator: Yizhi Liu, PhD, Zhongshan Ophthamic Center,Sun Yet-san University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 10, 2018

Primary Completion (Anticipated)

February 1, 2019

Study Completion (Anticipated)

February 1, 2019

Study Registration Dates

First Submitted

October 2, 2018

First Submitted That Met QC Criteria

October 6, 2018

First Posted (Actual)

October 9, 2018

Study Record Updates

Last Update Posted (Actual)

October 17, 2018

Last Update Submitted That Met QC Criteria

October 15, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2018KYPJ103

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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