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Trial Outcomes & Findings for Anterior Capsule Polishing Effect on Effective Lens Position (NCT NCT01598428)

NCT ID: NCT01598428

Last Updated: 2015-01-26

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

20 participants

Primary outcome timeframe

1 day，1 week, 1 month，3 months and 6 months postoperatively

Results posted on

2015-01-26

Participant Flow

Participant milestones

Participant milestones
Measure
Cataract
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
Overall Study
STARTED
20
Overall Study
COMPLETED
20
Overall Study
NOT COMPLETED
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Anterior Capsule Polishing Effect on Effective Lens Position

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Cataract
n=20 Participants
Age, Continuous
70.5 years
STANDARD_DEVIATION 7.6 • n=5 Participants
Sex: Female, Male
Female
10 Participants
n=5 Participants
Sex: Female, Male
Male
10 Participants
n=5 Participants
Region of Enrollment
China
20 participants
n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
Control
n=20 eyes
During cataract surgery, the anterior capsule was unpolished intraoperatively in this eye;
Anterior Capsule Polishing
n=20 eyes
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
Effective Lens Position
ELP 1 day postoperative
3.97 mm
Standard Deviation 0.27
4.02 mm
Standard Deviation 0.32
Effective Lens Position
ELP 1 week postoperative
3.93 mm
Standard Deviation 0.25
3.99 mm
Standard Deviation 0.29
Effective Lens Position
ELP 3 months postoperative
3.98 mm
Standard Deviation 0.24
3.97 mm
Standard Deviation 0.27
Effective Lens Position
ELP 6 months postoperative
3.92 mm
Standard Deviation 0.25
3.97 mm
Standard Deviation 0.28
Effective Lens Position
the root mean square of changes in the ELP(ELPrms)
0.06 mm
Standard Deviation 0.02
0.05 mm
Standard Deviation 0.02
Effective Lens Position
ELP 1 month postoperative
3.97 mm
Standard Deviation 0.23
3.99 mm
Standard Deviation 0.26

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure
Control
n=20 eyes
During cataract surgery, the anterior capsule was unpolished intraoperatively in this eye;
Anterior Capsule Polishing
n=20 eyes
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
Uncorrected Visual Acuity(UCVA)
UCVA 1 day postoperative
0.07 logMAR
Standard Deviation 0.10
0.07 logMAR
Standard Deviation 0.09
Uncorrected Visual Acuity(UCVA)
UCVA 3 months postoperative
0.10 logMAR
Standard Deviation 0.12
0.10 logMAR
Standard Deviation 0.08
Uncorrected Visual Acuity(UCVA)
UCVA 1 week postoperative
0.08 logMAR
Standard Deviation 0.09
0.08 logMAR
Standard Deviation 0.09
Uncorrected Visual Acuity(UCVA)
UCVA 1 month postoperative
0.09 logMAR
Standard Deviation 0.10
0.08 logMAR
Standard Deviation 0.09
Uncorrected Visual Acuity(UCVA)
UCVA 6 months postoperative
0.10 logMAR
Standard Deviation 0.11
0.10 logMAR
Standard Deviation 0.08

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
Control
n=20 eyes
During cataract surgery, the anterior capsule was unpolished intraoperatively in this eye;
Anterior Capsule Polishing
n=20 eyes
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
Refractive Error
the refractive error 1 day postoperative
-0.33 diopter(D)
Standard Deviation 0.18
-0.45 diopter(D)
Standard Deviation 0.18
Refractive Error
the refractive error 1 week postoperative
-0.42 diopter(D)
Standard Deviation 0.26
-0.53 diopter(D)
Standard Deviation 0.44
Refractive Error
the refractive error 1 month postoperative
-0.37 diopter(D)
Standard Deviation 0.24
-0.46 diopter(D)
Standard Deviation 0.47
Refractive Error
the refractive error 3 month postoperative
-0.36 diopter(D)
Standard Deviation 0.23
-0.48 diopter(D)
Standard Deviation 0.22
Refractive Error
the refractive error 6 months postoperative
-0.41 diopter(D)
Standard Deviation 0.22
-0.48 diopter(D)
Standard Deviation 0.21

Adverse Events

Cataract

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr.Yang Gao

Shandong University

Phone: 0086-543-89268587

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place