Effect of incision on visual outcomes after implantation of a trifocal diffractive intraocular lens

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN10086721

Enrollment

Registered

2018-06-23

Start date

2016-01-01

Completion date

Unknown

Last updated

2018-08-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients undergoing cataract surgery with implantation of a trifocal diffractive IOL Eye Diseases

Interventions

This prospective study enrolled patients randomly assigned to different groups. According to preoperative corneal astigmatism, patients were assigned into group A1 (0 ~ 0.50 D) or A2 (0.51 ~ 1.00 D) w

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients with cataract or presbyopia suitable for refractive lens exchange seeking spectacle independence who had preexisting corneal astigmatism of less than 1.00 D

Exclusion criteria

Exclusion criteria: Patients with a history of glaucoma, retinal detachment, corneal disease, irregular corneal astigmatism, abnormal iris, macular degeneration or retinopathy, neuro-ophthalmic disease, ocular inflammation, or previous ocular surgery

Design outcomes

Primary

Measure	Time frame
1. Corneal astigmatism measured with a Galilei device (Galilei G2, Ziemer ophthalmic systems AG, Port, Switzerland) at 1 day, 2 weeks, 1 month, or 3 months postoperatively 2. Uncorrected distance visual acuity (UDVA), uncorrected intermediate visual acuity (UIVA) and uncorrected near visual acuity (UNVA) obtained by the standard logarithmic chart at 1 day, 2 weeks, 1 month, or 3 months postoperatively 3. Total corneal wavefront aberration, root mean square value of corneal higher-order aberrations (RMS HOAs), spherical aberration (SA), coma, or trefoil measured with a Galilei device (Galilei G2, Ziemer ophthalmic systems AG, Port, Switzerland) at 1 day, 2 weeks, 1 month, or 3 months postoperatively	—

Measure

Time frame

1. Corneal astigmatism measured with a Galilei device (Galilei G2, Ziemer ophthalmic systems AG, Port, Switzerland) at 1 day, 2 weeks, 1 month, or 3 months postoperatively 2. Uncorrected distance visual acuity (UDVA), uncorrected intermediate visual acuity (UIVA) and uncorrected near visual acuity (UNVA) obtained by the standard logarithmic chart at 1 day, 2 weeks, 1 month, or 3 months postoperatively 3. Total corneal wavefront aberration, root mean square value of corneal higher-order aberrations (RMS HOAs), spherical aberration (SA), coma, or trefoil measured with a Galilei device (Galilei G2, Ziemer ophthalmic systems AG, Port, Switzerland) at 1 day, 2 weeks, 1 month, or 3 months postoperatively

—

Secondary

Measure	Time frame
1. The proportion of astigmatic axial length with the rule (WTR) (90°± 30°), against the rule (ATR) (0°to 30°or 150°to 180°), and oblique (30°to 60°or 120°to 150°) at pre operation and 3 months post operation 2. Surgically induced astigmatism (SIA) calculated using Jaffe/Clayman vector analysis at 3 months post operation 3. UDVA and CDVA between the subgroups obtained by the standard logarithmic chart pre operation	—

Measure

Time frame

1. The proportion of astigmatic axial length with the rule (WTR) (90°± 30°), against the rule (ATR) (0°to 30°or 150°to 180°), and oblique (30°to 60°or 120°to 150°) at pre operation and 3 months post operation 2. Surgically induced astigmatism (SIA) calculated using Jaffe/Clayman vector analysis at 3 months post operation 3. UDVA and CDVA between the subgroups obtained by the standard logarithmic chart pre operation

—

Countries

China

Contacts

Public ContactShasha Xue

xueshasha1104@126.com+86 (0)17863961151

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 23, 2026