Anterior Capsule Polishing Effect on Effective Lens Position

• Sponsor: Shandong University (Other)
• Overall Status: Completed
• CT.gov ID: NCT01598428
• Collaborator: (none)
• Enrollment: 20
• Location: 1
• Arm: 1
• Duration (Months): 12
• Patients Per Site Per Month: 1.7

Study Details

Study Description

Brief Summary

• The purpose of this study is to evaluate effects of anterior capsule polishing on effective lens position (ELP) and actual axial movement of the intraocular lens (IOL) by measuring anterior chamber depth (ACD)

• patients with bilateral age-related cataract undergo bilateral uneventful cataract surgeries with in-the- bag implantation of a single-piece hydrophobic acrylic foldable IOL (SN60WF). The anterior capsule was extensively polished using Whitman Shepherd Double-Ended Capsule Polisher in one eye randomly, and the other not. The ACD was measured 1day, 1 week, 1month, 3 months and 6 months with anterior segment Optical Coherence Tomograph (AS-OCT) postoperatively. The actual axial movement of IOL was defined as the root mean square (RMS) of the change in ELP at each visit.

Condition or Disease	Intervention/Treatment	Phase
Cataract	Procedure: anterior capsule polishing	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 20 participants
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Supportive Care
• Official Title: Effect of Anterior Capsule Polishing on Effective Lens Position After Cataract Surgery
• Study Start Date: Jan 1, 2013
• Actual Primary Completion Date: Jan 1, 2014
• Actual Study Completion Date: Jan 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Other: cataract	Procedure: anterior capsule polishing; polish the anterior capsule and the equator of capsule extensively with a Whitman Shepherd Double-Ended Capsule Polisher

Outcome Measures

Primary Outcome Measures

1. Effective Lens Position [1 day，1 week, 1 month，3 months and 6 months postoperatively]

   Effective lens position was measured with anterior chamber depth 1 day，1 week, 1 month as well as 3 months and 6 months postoperatively using anterior segment Optical Coherence Tomograph. The anterior chamber depth defined as the distance between the posterior surface of the corneal and anterior surface of intraocular lens in the pupil center along the optical axis. The actual movement of intraocular lenses was defined as the root mean square of changes in the effective lens position at each visit.

Secondary Outcome Measures

1. Uncorrected Visual Acuity(UCVA) [1 day，1 week, 1 month as well as 3 months and 6 months postoperatively]

   The UCVA was recorded in logMAR units at each vist

2. Refractive Error [1 day，1 week, 1 month as well as 3 months and 6 months postoperatively]

   auto refraction was performed at each visit. Spherical equivalent refraction (SER) (sphere +cylinder/2) was used in subsequent calculations.

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• bilateral age-related cataract

• good overall physical constitution

• uneventful surgeries of both eyes with in-the-bag IOL implantation

Exclusion Criteria:

• history of intraocular surgery or laser therapy

• history of ocular trauma or ocular disease

• high myopia

• diabetes

• severe retinal pathology

• patients who could not return on time

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Ophtalmology,Qianfoshan Hospital,Shandong University	Jinan	Shandong	China	250013

Sponsors and Collaborators

• Shandong University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Yang Gao, Principal Investigator, Shandong University
• ClinicalTrials.gov Identifier: NCT01598428
• Other Study ID Numbers: YGao
• First Posted: May 15, 2012
• Last Update Posted: Jan 26, 2015
• Last Verified: Jan 1, 2015

• Keywords provided by Yang Gao, Principal Investigator, Shandong University: age related cataract; phacoemulsification; anterior capsule polishing; optical coherence tomography; anterior chamber depth
• Additional relevant MeSH terms: Cataract

Study Results

Participant Flow

Arm/Group Title	Cataract
Arm/Group Description	During cataract surgery, the anterior capsule was unpolished intraoperatively in one eye; the anterior capsule and the equator of capsule was extensively polished intraoperatively in the other eye. Anterior capsule polishing: polish the anterior capsule and the equator of capsule extensively with a Whitman Shepherd Double-Ended Capsule Polisher
Period Title: Overall Study
STARTED	20
COMPLETED	20
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Cataract
Arm/Group Description
Overall Participants	20
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	70.5 (7.6)
Sex: Female, Male (Count of Participants)
Female	10 50%
Male	10 50%
Region of Enrollment (participants) [Number]
China	20 100%

Outcome Measures

1. Primary Outcome

Title	Effective Lens Position
Description	Effective lens position was measured with anterior chamber depth 1 day，1 week, 1 month as well as 3 months and 6 months postoperatively using anterior segment Optical Coherence Tomograph. The anterior chamber depth defined as the distance between the posterior surface of the corneal and anterior surface of intraocular lens in the pupil center along the optical axis. The actual movement of intraocular lenses was defined as the root mean square of changes in the effective lens position at each visit.
Time Frame	1 day，1 week, 1 month，3 months and 6 months postoperatively

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Control	Anterior Capsule Polishing
Arm/Group Description	During cataract surgery, the anterior capsule was unpolished intraoperatively in this eye;	During cataract surgery, the anterior capsule and the equator of capsule was extensively polished intraoperatively in this eye. Anterior capsule polishing: polish the anterior capsule and the equator of capsule extensively with a Whitman Shepherd Double-Ended Capsule Polisher
Measure Participants	20	20
Measure eyes	20	20
ELP 1 day postoperative	3.97 (0.27)	4.02 (0.32)
ELP 1 week postoperative	3.93 (0.25)	3.99 (0.29)
ELP 1 month postoperative	3.97 (0.23)	3.99 (0.26)
ELP 3 months postoperative	3.98 (0.24)	3.97 (0.27)
ELP 6 months postoperative	3.92 (0.25)	3.97 (0.28)
the root mean square of changes in the ELP(ELPrms)	0.06 (0.02)	0.05 (0.02)

2. Secondary Outcome

Title	Uncorrected Visual Acuity(UCVA)
Description	The UCVA was recorded in logMAR units at each vist
Time Frame	1 day，1 week, 1 month as well as 3 months and 6 months postoperatively

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Control	Anterior Capsule Polishing
Arm/Group Description	During cataract surgery, the anterior capsule was unpolished intraoperatively in this eye;	During cataract surgery, the anterior capsule and the equator of capsule was extensively polished intraoperatively in this eye. Anterior capsule polishing: polish the anterior capsule and the equator of capsule extensively with a Whitman Shepherd Double-Ended Capsule Polisher
Measure Participants	20	20
Measure eyes	20	20
UCVA 1 day postoperative	0.07 (0.10)	0.07 (0.09)
UCVA 1 week postoperative	0.08 (0.09)	0.08 (0.09)
UCVA 1 month postoperative	0.09 (0.10)	0.08 (0.09)
UCVA 3 months postoperative	0.10 (0.12)	0.10 (0.08)
UCVA 6 months postoperative	0.10 (0.11)	0.10 (0.08)

3. Secondary Outcome

Title	Refractive Error
Description	auto refraction was performed at each visit. Spherical equivalent refraction (SER) (sphere +cylinder/2) was used in subsequent calculations.
Time Frame	1 day，1 week, 1 month as well as 3 months and 6 months postoperatively

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Control	Anterior Capsule Polishing
Arm/Group Description	During cataract surgery, the anterior capsule was unpolished intraoperatively in this eye;	During cataract surgery, the anterior capsule and the equator of capsule was extensively polished intraoperatively in this eye. Anterior capsule polishing: polish the anterior capsule and the equator of capsule extensively with a Whitman Shepherd Double-Ended Capsule Polisher
Measure Participants	20	20
Measure eyes	20	20
the refractive error 1 day postoperative	-0.33 (0.18)	-0.45 (0.18)
the refractive error 1 week postoperative	-0.42 (0.26)	-0.53 (0.44)
the refractive error 1 month postoperative	-0.37 (0.24)	-0.46 (0.47)
the refractive error 3 month postoperative	-0.36 (0.23)	-0.48 (0.22)
the refractive error 6 months postoperative	-0.41 (0.22)	-0.48 (0.21)

Adverse Events

Arm/Group Title	Cataract
Arm/Group Description
All Cause Mortality
	Cataract
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Cataract
	Affected / at Risk (%)	# Events
Total	0/20 (0%)
Other (Not Including Serious) Adverse Events
	Cataract
	Affected / at Risk (%)	# Events
Total	0/20 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.