Posterior Capsulotomy in Cataract Complicated With Primary Posterior Capsule Opacification.

Cataract Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03701139
• Other study ID #: 2018KYPJ103
• Status: Recruiting
• Phase: N/A
• Start date: October 10, 2018
• Est. completion date: February 2019

Study information

• Verified date: October 2018
• Source: Zhongshan Ophthalmic Center, Sun Yat-sen University
• Contact: Xuhua Tan, PhD
• Phone: +8613926019722
• Email: doctxh[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: February 2019
• Est. primary completion date: February 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Capsule Opacification
• Cataract
• Posterior Capsule Opacification

Intervention

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.
• 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.

Locations

Country	Name	City	State
China	Zhongshan Ophthalmic Center, Sun Yat-sen University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Zhongshan Ophthalmic Center, Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	LogMAR visual acuity 1 month postoperatively	Best corrected visual acuity (LogMAR) will be measured 1 month postoperatively.	1 month
Secondary	Dysfunctional lens index (DLI)	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
Secondary	Internal higher order aberration (HOAs)	TInternal higher order aberration (HOAs) in micrometer can quantify the intraocular optical quality and will be measured by iTrace aberrometer.	3 months
Secondary	Object scatter index (OSI)	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
Secondary	Modulation transfer function cut off (MTF cut off)	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
Secondary	Strehl ratio (SR)	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
Secondary	Predicted visual acuity (PVA) with contrasts of 100%, 20% and 10%	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
Secondary	Rate of ocular hypertension	Diagnosis of ocular hypertension is based on IOP greater than 21 mm Hg and the rate of ocular hypertension is calculated.	3 months
Secondary	Rate of ocular macular edema	The central macular thickness in micrometer is measured by optical coherence tomography (OCT) and the rate of ocular macular edema is calculated.	3 months
Secondary	Rate of retinal detachment	Retinal detachment following surgical or laser posterior capsulotomy is documented and the rate of Retinal detachment is calculated.	3 months
Secondary	Rate of intraocular lens damage	The rate of intraocular lens damage by Nd:YAG laser is documented.	3 months
Secondary	Visual-functioning index 7 score	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.; nighttime driving; reading small print; watching television; seeing steps, stairs, or curbs; reading traffic, street, or store signs; cooking; doing fine handwork	3 months