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Completed

NCT Number: NCT03817151

Clinical Observation of the Transscleral Suture Fixation of Posterior Chamber Intraocular Lens in Eyes With Inadequate Capsule Support

To present the follow-up outcomes of transscleral suture fixation of posterior chamber intraocular lens (PCIOL) in eyes with inadequate capsule support.

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Key information

Conditions

Absence of Capsule Support Aphakia Eye Diseases Lens Diseases

Age range

10 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Second Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310009, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients who underwent transscleral suture fixation of PCIOL
  • Time between the primary surgeries was at least 3 months

Exclusion criteria

  • Active intraocular inflammation
  • The intraocular pressure (IOP) was higher than 25 mmHg
  • The endothelial cell count (ECC) was more than 1,200 cells/mm2

Treatment and study plan

posterior chamber intraocular lens implantation

Procedure

patients who underwent transscleral sutured posterior chamber intraocular lens implantation

Primary outcomes

  1. Visual function

    Time frame: 1day postoperation

    Best corrected visual acuity (BCVA) measured using a decimal chart

  2. Visual function

    Time frame: 1 week postoperation

    Best corrected visual acuity (BCVA) measured using a decimal chart

  3. Visual function

    Time frame: 1 month postoperation

    Best corrected visual acuity (BCVA) measured using a decimal chart

  4. Visual function

    Time frame: 3 month postoperation

    Best corrected visual acuity (BCVA) measured using a decimal chart

  5. Visual function

    Time frame: 1 day postoperation

    uncorrected distance visual acuity (UDVA) measured using a decimal chart

  6. Visual function

    Time frame: 1 week postoperation

    uncorrected distance visual acuity (UDVA) measured using a decimal chart

  7. Visual function

    Time frame: 1 month postoperation

    uncorrected distance visual acuity (UDVA) measured using a decimal chart

  8. Visual function

    Time frame: 3 month postoperation

    uncorrected distance visual acuity (UDVA) measured using a decimal chart

Secondary outcomes

  1. intraocular pressure

    Time frame: 1 day, 1 week, 1 month, and 3 month postoperation

    intraocular pressure

  2. PCIOL tilt degree

    Time frame: 3 month postoperation

    PCIOL tilt degree measured using Ultrasound biomicroscope

  3. PCIOL decentration degree

    Time frame: 3 month postoperation

    PCIOL tilt degree measured using Ultrasound biomicroscope

  4. endothelial cell count

    Time frame: 1 week, 1 month, and 3 month postoperation

    endothelial cell count

  5. anterior chamber depth

    Time frame: 3 month postoperation

    anterior chamber depth measured using Ultrasound biomicroscope

Sponsors and collaborators

Lead sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Other

Registry information

Official study title

Clinical Observation of Transscleral Suture Fixation of Posterior Chamber Intraocular Lens in Eyes With Inadequate Capsule Support

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jan 25, 2019
Registry last updated
Jan 25, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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