Clinical trial NCT05797298: Toric Intraocular Lens (IOL) Implantation for Management of Cataracts
Official title: Plate-haptic Toric Intraocular Lens (IOL) Implantation for Management of Cataracts
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Toric Intraocular Lens Stability
Visual Quality
Lead sponsor: Eye & ENT Hospital of Fudan University
Sponsor class: OTHER
First posted: 2023-04-04
Enrollment: 3000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Cataract patients who underwent uneventful lens phacoemulsification and toric IOL implantation.

Brief summary: This study included cataract patients who underwent toric intraocular lens (IOL) implantation, which aimed to evaluate the stability and clinical visual quality of toric IOLs.

Detailed description: This study included cataract patients who underwent the implantation of toric intraocular lens (IOL) with haptic design, which aimed to evaluate the stability and clinical visual quality of toric IOLs.

Eligibility criteria: Inclusion Criteria:

* Cataract

Exclusion Criteria:

* • small pupil

  * zonular dehiscence
  * preexisting corneal pathology
  * glaucoma
  * uveitis
  * a history of ocular trauma or surgery
  * severe intraoperative and postoperative complications

Primary outcomes:
measure: IOL rotation degree at one hour
timeFrame: one hour
measure: IOL rotation degree at one day
timeFrame: one day
measure: IOL rotation degree at three days
timeFrame: three days
measure: IOL rotation degree at one week
timeFrame: one week
measure: IOL rotation degree at two weeks
timeFrame: two weeks
measure: IOL rotation degree at one month
timeFrame: one month
measure: IOL rotation degree at three months
timeFrame: three months
measure: IOL rotation degree at six months
timeFrame: six months
measure: IOL rotation degree at one year
timeFrame: one year
measure: IOL rotation degree at three years
timeFrame: three years
measure: IOL tilt at one week
timeFrame: one week
measure: IOL tilt at two weeks
timeFrame: two weeks
measure: IOL tilt at one month
timeFrame: one month
measure: IOL tilt at three months
timeFrame: three months
measure: IOL tilt at six months
timeFrame: six months
measure: IOL tilt at one year
timeFrame: one year
measure: IOL tilt at three years
timeFrame: three years
measure: IOL decentration at one week
timeFrame: one week
measure: IOL decentration at two weeks
timeFrame: two weeks
measure: IOL decentration at one month
timeFrame: one month
measure: IOL decentration at three months
timeFrame: three months
measure: IOL decentration at six months
timeFrame: six months
measure: IOL decentration at one year
timeFrame: one year
measure: IOL decentration at three years
timeFrame: three years
Secondary outcomes:
measure: visual quality at one week
timeFrame: one week
measure: visual quality at two weeks
timeFrame: two weeks
measure: visual quality at one month
timeFrame: one month
measure: visual quality at three months
timeFrame: three months
measure: visual quality at six months
timeFrame: six months
measure: visual quality at one year
timeFrame: one year
measure: visual quality at three years
timeFrame: three years
Other outcomes:
measure: visual acuity at one day
timeFrame: one day
measure: visual acuity at three days
timeFrame: three days
measure: visual acuity at one week
timeFrame: one week
measure: visual acuity at two weeks
timeFrame: two weeks
measure: visual acuity at one month
timeFrame: one month
measure: visual acuity at three months
timeFrame: three months
measure: visual acuity at six months
timeFrame: six months
measure: visual acuity at one year
timeFrame: one year
measure: visual acuity at three years
timeFrame: three years
Locations:
city: Shanghai
country: China
facility: Eye & ENT Hospital of Fudan University
state: Shanghai
city: Shanghai
country: China
facility: Eye & ENT Hospital of Fudan University
Study officials:
affiliation: Eye & ENT Hospital of Fudan University
name: Jin Yang, PhD
role: PRINCIPAL_INVESTIGATOR
References: