Toric Intraocular Lens (IOL) Implantation for Management of Cataracts

Visual Quality Clinical Trial

Official title:

Plate-haptic Toric Intraocular Lens (IOL) Implantation for Management of Cataracts

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05797298
• Other study ID #: Toric IOL
• Status: Recruiting
• Start date: June 1, 2019
• Est. completion date: May 31, 2024

Study information

• Verified date: April 2023
• Source: Eye & ENT Hospital of Fudan University
• Contact: Dongmei Ma, MD
• Phone: 15629089882
• Email: docmdm[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3000
• Est. completion date: May 31, 2024
• Est. primary completion date: March 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Cataract
• Visual Quality

Locations

Country	Name	City	State
China	Eye & ENT Hospital of Fudan University	Shanghai	Shanghai
China	Eye & ENT Hospital of Fudan University	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Eye & ENT Hospital of Fudan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	visual acuity at one day	uncorrected distance visual acuity (UDVA) and corrected distance visual acuity (CDVA) were recorded after surgery at one day	one day
Other	visual acuity at three days	uncorrected distance visual acuity (UDVA) and corrected distance visual acuity (CDVA) were recorded after surgery at three days	three days
Other	visual acuity at one week	uncorrected distance visual acuity (UDVA) and corrected distance visual acuity (CDVA) were recorded after surgery at one week	one week
Other	visual acuity at two weeks	uncorrected distance visual acuity (UDVA) and corrected distance visual acuity (CDVA) were recorded after surgery at two weeks	two weeks
Other	visual acuity at one month	uncorrected distance visual acuity (UDVA) and corrected distance visual acuity (CDVA) were recorded after surgery at one month	one month
Other	visual acuity at three months	uncorrected distance visual acuity (UDVA) and corrected distance visual acuity (CDVA) were recorded after surgery at three months	three months
Other	visual acuity at six months	uncorrected distance visual acuity (UDVA) and corrected distance visual acuity (CDVA) were recorded after surgery at six months	six months
Other	visual acuity at one year	uncorrected distance visual acuity (UDVA) and corrected distance visual acuity (CDVA) were recorded after surgery at one year	one year
Other	visual acuity at three years	uncorrected distance visual acuity (UDVA) and corrected distance visual acuity (CDVA) were recorded after surgery at three years	three years
Primary	IOL rotation degree at one hour	After the pupil was dilated, the IOL axis was recorded using the same slit-lamp microscope. IOL rotation was defined as the difference between the target and final axis.	one hour
Primary	IOL rotation degree at one day	After the pupil was dilated, the IOL axis was recorded using the same slit-lamp microscope. IOL rotation was defined as the difference between the target and final axis.	one day
Primary	IOL rotation degree at three days	After the pupil was dilated, the IOL axis was recorded using the same slit-lamp microscope. IOL rotation was defined as the difference between the target and final axis.	three days
Primary	IOL rotation degree at one week	After the pupil was dilated, the IOL axis was recorded using the same slit-lamp microscope. IOL rotation was defined as the difference between the target and final axis.	one week
Primary	IOL rotation degree at two weeks	After the pupil was dilated, the IOL axis was recorded using the same slit-lamp microscope. IOL rotation was defined as the difference between the target and final axis.	two weeks
Primary	IOL rotation degree at one month	After the pupil was dilated, the IOL axis was recorded using the same slit-lamp microscope. IOL rotation was defined as the difference between the target and final axis.	one month
Primary	IOL rotation degree at three months	After the pupil was dilated, the IOL axis was recorded using the same slit-lamp microscope. IOL rotation was defined as the difference between the target and final axis.	three months
Primary	IOL rotation degree at six months	After the pupil was dilated, the IOL axis was recorded using the same slit-lamp microscope. IOL rotation was defined as the difference between the target and final axis.	six months
Primary	IOL rotation degree at one year	After the pupil was dilated, the IOL axis was recorded using the same slit-lamp microscope. IOL rotation was defined as the difference between the target and final axis.	one year
Primary	IOL rotation degree at three years	After the pupil was dilated, the IOL axis was recorded using the same slit-lamp microscope. IOL rotation was defined as the difference between the target and final axis.	three years
Primary	IOL tilt at one week	The tilt data were obtained from the wavefront mode of the OPD-Scan III aberrometer.	one week
Primary	IOL tilt at two weeks	The tilt data were obtained from the wavefront mode of the OPD-Scan III aberrometer.	two weeks
Primary	IOL tilt at one month	The tilt data were obtained from the wavefront mode of the OPD-Scan III aberrometer.	one month
Primary	IOL tilt at three months	The tilt data were obtained from the wavefront mode of the OPD-Scan III aberrometer.	three months
Primary	IOL tilt at six months	The tilt data were obtained from the wavefront mode of the OPD-Scan III aberrometer.	six months
Primary	IOL tilt at one year	The tilt data were obtained from the wavefront mode of the OPD-Scan III aberrometer.	one year
Primary	IOL tilt at three years	The tilt data were obtained from the wavefront mode of the OPD-Scan III aberrometer.	three years
Primary	IOL decentration at one week	Decentration was defned as the distance between the center of the toric IOL and the visual axis and was calculated using Adobe Photoshop software on the retro image exported from the OPD-scan aberrometer.	one week
Primary	IOL decentration at two weeks	Decentration was defned as the distance between the center of the toric IOL and the visual axis and was calculated using Adobe Photoshop software on the retro image exported from the OPD-scan aberrometer.	two weeks
Primary	IOL decentration at one month	Decentration was defned as the distance between the center of the toric IOL and the visual axis and was calculated using Adobe Photoshop software on the retro image exported from the OPD-scan aberrometer.	one month
Primary	IOL decentration at three months	Decentration was defned as the distance between the center of the toric IOL and the visual axis and was calculated using Adobe Photoshop software on the retro image exported from the OPD-scan aberrometer.	three months
Primary	IOL decentration at six months	Decentration was defned as the distance between the center of the toric IOL and the visual axis and was calculated using Adobe Photoshop software on the retro image exported from the OPD-scan aberrometer.	six months
Primary	IOL decentration at one year	Decentration was defned as the distance between the center of the toric IOL and the visual axis and was calculated using Adobe Photoshop software on the retro image exported from the OPD-scan aberrometer.	one year
Primary	IOL decentration at three years	Decentration was defned as the distance between the center of the toric IOL and the visual axis and was calculated using Adobe Photoshop software on the retro image exported from the OPD-scan aberrometer.	three years
Secondary	visual quality at one week	visual acuity was evaluated by OPD-Scan III aberrometer.	one week
Secondary	visual quality at two weeks	visual acuity was evaluated by OPD-Scan III aberrometer.	two weeks
Secondary	visual quality at one month	visual acuity was evaluated by OPD-Scan III aberrometer.	one month
Secondary	visual quality at three months	visual acuity was evaluated by OPD-Scan III aberrometer.	three months
Secondary	visual quality at six months	visual acuity was evaluated by OPD-Scan III aberrometer.	six months
Secondary	visual quality at one year	visual acuity was evaluated by OPD-Scan III aberrometer.	one year
Secondary	visual quality at three years	visual acuity was evaluated by OPD-Scan III aberrometer.	three years